NA 03.600.004Recalls & reported problems
Synthes GmbH · CERVICAL PLATE BENDER · 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 10705034711782), received between Oct 31, 2019 and Oct 31, 2019 — 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 16, 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.
MalfunctionOct 31, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN PROCEDURE WAS SCHEDULED FOR (B)(6) 2019. DURING DEVICE INSPECTION BY THE DISTRIBUTOR AND THE HOSPITAL, IT WAS FOUND THAT SOME COMPONENTS OF THE BEND-PLIER HAD BEEN DISMANTLED. AFTER INVESTIGATION, IT WAS CONFIRMED THAT BOTH THE DISTRIBUTION CENTER AND THE HOSPITAL HAD NOT DISMANTLED THOSE COMPONENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9261197 ↗
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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