NA 245.028Recalls & reported problems
Synthes GmbH · 3.5MM LOW PROFILE RECONSTRUCTION PLATE 8 HOLES · Class 2 · Implant
Data updated Oct 16, 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 10886982169419), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF HIP AND HARDWARE REMOVAL OF ONE (1) LOW PRO RECONSTRUCTION PLATE, FOUR (4) CANCELLOUS SCREWS, AND TWO (2) CORTEX SCREWS DUE TO AN UNKNOWN ALLEGATION/MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 3.5 LOW PRO RECONSTRUCTION PL 8 HOLES THIS REPORT IS 1 OF 7 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12207436 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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