NA SD420.427Recalls & reported problems
Synthes GmbH · PSI SD420.427 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587069746), received between Apr 8, 2020 and Apr 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Missing Information” (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
- Missing Information1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2020Missing Information; Missing Information
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT SPECIFIC IMPLANT HAD INCORRECT SPACE PLATING HOLES FOR THE REQUESTED PLATES. THE SALES CONSULTANT INDICATED THAT THEY INTEND TO USE A DIFFERENT STYLE PLATE TO FIT THE CURRENT HOLE SYSTEM WITHOUT OBSTRUCTING ORIGINAL SURGERY DATE AND TIME. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 9936413 ↗
Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices
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- AccuShape® MC-SPK40Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- AccuShape® MC-SPK30Medcad · Plate, Cranioplasty, Preformed, Non-Alterable13 reports
- NA SD800.434Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE11 reports
- 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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