NA SD389.881Recalls & reported problems
Synthes GmbH · SERRATED CURETTE-7.5MM WIDTH STRAIGHT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034708416), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2020Break; Break
IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION L2-PELVIS TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). DURING THE PROCEDURE, A STRAIGHT SERRATED CURETTE WAS BROKEN WHILE PERFORMING A DISCECTOMY. THE L2 LEVEL WAS COLLAPSED AND HIGHLY OSSIFIED AND WHILE PERFORMING THE DISCECTOMY AT THIS LEVEL THE CURETTES BECAME STUCK AND WERE BROKEN INTO 3 PIECES WHILE REMOVING. AN ALTERNATE NON-SERRATED CURETTE WAS USED TO FINISH, AND ALL PIECES WERE CONFIRMED REMOVED BY FLUOROSCOPY. THE ORIGINAL IMPLANTS WERE NOT SYNTHES, THE SURGEON RAN A SECOND ROD FROM ILEUM-L2 TO REINFORCE THE WHOLE STRUCTURE SINCE IT IS NOT CONTINUOUS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS IS REPORT 01 OF 01 OF (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9694117 ↗
Other CURETTE devices
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- Centurion I68040Centurion Medical Products Corporation · CURETTE1 recall0 reports
- Centurion I68380Centurion Medical Products Corporation · CURETTE1 recall0 reports
- Centurion 67050Centurion Medical Products Corporation · CURETTE1 recall0 reports
- Centurion I68340Centurion Medical Products Corporation · CURETTE1 recall0 reports
- Centurion I67970Centurion Medical Products Corporation · CURETTE1 recall0 reports
- Centurion I68480Centurion Medical Products Corporation · CURETTE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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