NA 388.961Recalls & reported problems
Synthes GmbH · ROD BENDER WITH BEND RADIUS ADJUSTMENT · Class 1
Data updated Oct 16, 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 10705034774008), received between Feb 10, 2021 and Feb 10, 2021 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2021No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SURGERY, THE SURGEON WAS USING A SYNTHES FRENCH ROD BENDER TO CONTOUR A 5.5MM EXPEDIUM ROD. WHILE BENDING THE ROD, THE CENTER BOLT CAME OUT AND THE BENDER SEPARATED INTO FOUR (4) PIECES. IT WAS REMOVED FROM THE FIELD AND NEW BENDER WAS UTILIZED. NO FURTHER ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ROD BENDER WITH BEND RADIUS ADJUSTMENT. THIS IS REPORT 1 OF 1 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11306551 ↗
Other BENDER devices
- MONARCH 277030000Depuy Spine, LLC · BENDER15 reports
- EXPEDIUM 299704190Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704200Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704195Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704185Medos International Sàrl · BENDER8 reports
- ALTALYNE 5161-04-1700Medos International Sàrl · BENDER8 reports
- NA 03.161.057Synthes GmbH · BENDER5 reports
- EXPEDIUM 279763865Medos International Sàrl · BENDER4 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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