NA SD420.526Recalls & reported problems
Synthes GmbH · PSI SD420.526 TITANIUM IMPLANT · 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 10887587068527), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
Patient problems
- Failure of Implant1
- 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.
InjuryJan 13, 2020Defective Device; Defective Device
IT WAS REPORTED ON (B)(6) 2019, A PATIENT-SPECIFIC IMPLANT (PSI) MANUFACTURED BY DEPUY SYNTHES WAS NOT MANUFACTURED TO THE SPECIFICATIONS FOR A PSI CASE. THROUGH EMAILS THE DESIGN WAS CONFIRMED TO HAVE HOLES DRILLED INTO THE TITANIUM IMPLANT TO FIT A TI MATRIXNEURO BOX PLATE (04.503.073) BUT IT WAS MANUFACTURED WITH DRILL HOLES SPACED FOR TI MATRIXNEURO BOX PLATE (04.503.065). LUCKILY SURGEON WAS ABLE TO FIND 4 X 04.503.065 FROM THE OTHER TRAYS AND THE SURGEON AND PATIENT WERE HAPPY BUT THIS COULD HAVE GONE VERY WRONG. IT IS UNKNOWN IF THERE WERE A PROCEDURE AND PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 9582021 ↗
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- NA SD800.427Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- NA SD800.433Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE8 reports
- IPS 60-000-23-09KLS-Martin L.P. · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE7 reports
- NA SD800.540Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE6 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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