NA 04.613.664Recalls & reported problems
Synthes GmbH · 4.5MM TI CERV SELF-RETAIN SCR SLF-TPNG/VARIABLE ANGLE 14MM · Class 2 · Implant
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 10705034737881), received between Sep 26, 2023 and Sep 26, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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
- Compatibility Problem1
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.
MalfunctionSep 26, 2023Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT ON (B)(6) 2023, THAT DURING PLACEMENT OF THE VECTRA PLATE AND SCREWS, SURGEON FOUND THAT HE COULD NOT ADVANCE A 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM SCREW BEYOND THE LOCKING MECHANISM ON THE PLATE. FLUOROSCOPY WAS USED, EVERYTHING LOOKED ACCEPTABLE FOR SCREW PLACEMENT AND ANGULATION. HE REMOVED THE SCREW, AND ATTEMPTED TO PLACE A SHORTER RESCUE SCREW 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM IN ITS PLACE. THAT SCREW WOULD ALSO NOT PASS THE LOCKING MECHANISM. HE REMOVED THE RESCUE SCREW AND INSPECTED THE PLATE VISUALLY, AND SAW DIFFERENCES BETWEEN THAT SCREW HOLE AND THE OTHERS. HE ELECTED TO REMOVE THE ENTIRE CONSTRUCT AND START NEW. THIS LED TO MORE 4.0 TI CERV SLF RTN SCR SLF-TPNG/VA 16MM IMPLANTS BEING WASTED AND ARE PART OF THIS COMPLAINT. THE SURGERY WAS EASILY COMPLETED WITH A MINIMAL AMOUNT OF EXTRA TIME (UNDER 5 MINUTES). NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 4.5 TI CERV SLF RTN SCR SLF-TPNG/VA 14MM. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17821443 ↗
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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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