GXRClass 2
Cover, Burr Hole
FDA adverse event reports and recall history for cover, burr hole (product code GXR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 210
- Deaths
- 0
- Injuries
- 89
- Malfunctions
- 118
Reports per year
412
413
214
715
716
717
4518
2819
1620
2821
1322
1123
324
1125
126
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
- Open, ClassifiedProcess control
Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Excess nylon flash on the clip.
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