NA 02.221.180SRecalls & reported problems
Synthes GmbH · CONNECTING SCR F/VA PPFX GT RING ATTCHMT PLATE/STERILE · 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 10886982276124), received between Mar 7, 2025 and Mar 7, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 7, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE PFFX GREATER TROCH ATTACHMENT PLATES WERE NOT SCREWING INTO PLATE. USER TRIED SEVERAL ATTACHMENTS AND SEVERAL PLATES. USER THOUGHT THERE WAS AN ISSUE WITH ONE OF THE ATTACHMENT PLATE SCREWS WHICH THEN DEFORMED SOME PLATES. DOCTOR PROCEEDED WITH SURGERY WITHOUT ATTACHMENT PLATE. SURGERY WAS DELAYED BY 10 MINUTES DUE TO REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE NOT GENERATED. UPON MANUFACTURER INSPECTION OF RETURNED DEVICES, IT WAS NOTED THAT THE CONNECTING SCR F/VA PPFX GT RING ATTACHMENT PLATE/STERILE WAS UNABLE TO ASSEMBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21548848 ↗
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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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