NA SD800.534Recalls & reported problems
Synthes GmbH · PSI SD800.534 PEEK 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 10887587065939), received between Oct 11, 2019 and Oct 11, 2019 — 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
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PSI PEEK IMPLANT HAD TO BE REMOVED DUE TO INFECTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS IS REPORT 1 FOR 3 (B)(4).
Patient problems: Unspecified Infection
MAUDE report 9180208 ↗
Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices
- NA SD800.440Synthes GmbH · PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE22 reports
- 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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