NA 03.632.039Recalls & reported problems
Synthes GmbH · IN SITU BENDER-LEFT FOR 5.5MM RODS · 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 10705034718972), received between Nov 12, 2021 and Nov 12, 2021 — 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 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.
MalfunctionNov 12, 2021Break; Break
IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF A RETURNED DEVICE AT MILLSTONE THE IN SITU BENDER-LEFT FOR 5.5MM RODS WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) IN SITU BENDER-LEFT FOR 5.5MM RODS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12805749 ↗
Other BENDER devices
- MONARCH 277030000Depuy Spine, LLC · BENDER15 reports
- EXPEDIUM 299704200Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704190Medos International Sàrl · BENDER9 reports
- EXPEDIUM 299704195Medos International Sàrl · BENDER9 reports
- ALTALYNE 5161-04-1700Medos International Sàrl · BENDER8 reports
- EXPEDIUM 299704185Medos International Sàrl · BENDER8 reports
- NA 03.161.057Synthes GmbH · BENDER5 reports
- EXPEDIUM 279763860Medos 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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