Prosthesis, Intervertebral Disc
FDA adverse event reports and recall history for prosthesis, intervertebral disc (product code MJO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,127
- Deaths
- 11
- Injuries
- 5,043
- Malfunctions
- 1,046
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-05-01Open, ClassifiedLabeling mix-ups
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
- 2026-05-01Open, ClassifiedLabeling mix-ups
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
- 2026-02-17Open, ClassifiedProcess control
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Products were mislabeled as the 6mm product but included the 5 mm product.
- 2024-09-24Open, ClassifiedProcess control
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
- 2024-09-24Open, ClassifiedProcess control
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
- 2023-08-24Open, ClassifiedUnder Investigation by firm
GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e) A13131789, f) A13132012, g) B13111014, h) B13111015, i) B13111016, j) B13111017, k) B13111025, l) B13111026, m) B13111027, n) B13111034, o) B13111035, p) B13111036; intervertebral fusion device - cervical
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- 2007-12-19TerminatedDevice Design
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- 2007-12-19TerminatedDevice Design
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, SIZE 6 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- 2007-12-19TerminatedDevice Design
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, SIZE 6 X 16, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
- 2007-12-19TerminatedDevice Design
Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.
Monitor prosthesis, intervertebral disc automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.