NA 04.130.351Recalls & reported problems
Synthes GmbH · 2.0MM TI VAL STRAIGHT PLATE 12 HOLES · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982113443), received between Oct 14, 2019 and Oct 14, 2019 — classified as 1 injury.
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 Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2019Break; Break
(B)(6)2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. UPON INSERTION OF LUPINE, THE VARIABLE ANGLE LOCKING PLATE WAS BUSTED. A NEW IMPLANT WAS OPENED AND WAS DRILLED IN A DIFFERENT SPOT. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE BUT WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SEVEN (7) MINUTES OF SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: No Code Available
MAUDE report 9188866 ↗
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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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