NA 389.204Recalls & reported problems
Synthes GmbH · IMPLANT HOLDER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034775043), received between Jan 16, 2017 and Apr 15, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Component Missing1
Patient problems
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2020Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A SPINE PROCEDURE IT WAS DISCOVERED THAT THE SYNEX CAGE HOLDER WAS BROKEN. THIS IS A CRUCIAL INSTRUMENT FOR 80% OF THE CORPECTOMY PROCEDURE. THE PROCEDURE WAS DELAYED 90 MINUTES AND SURGEON HAD TO USE MULTIPLE FORCEPS WHICH DID NOT PROVIDE STABILITY , SO CLOSED TO SPINAL CORD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNSTABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9964405 ↗MalfunctionJan 16, 2017Break; Component Missing; Break; Component Missing
DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: (B)(6) REPORTED THAT DURING THE CLEANING PROCESS, IT WAS DISCOVERED THAT THE IMPLANT HOLDER IS BROKEN. DURING WASHING OF THE IMPLANT HOLDER, THE SCREW WHICH HOLDS THE PROXIMAL PORTIONS WAS LOST. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THE INSTRUMENT IS NOT WORKING AS IT SHOULD AND WAS LEFT IN THE SYSTEM AT THE HOSPITAL. NO PATIENT WAS AFFECTED BY THIS AND THERE WAS NO SURGICAL DELAY REPORTED. THIS COMPLAINT INVOLVES 2 DEVICES. THIS REPORT IS 1 OF 1 FOR THIS COMPLAINT INVOLVES 2 DEVICES.
Patient problems: No Patient Involvement
MAUDE report 6254802 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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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