AVS Anchor-C 48328007Recalls & reported problems
Stryker Corporation · INSERTER TIP · Class 2
All models of AVS Anchor-C (10)
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 04546540679154), received between May 16, 2016 and May 16, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2016Break; Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT; THE SURGEON REPORTED THAT THERE WERE 2 INSTRUMENTS DAMAGED / BROKEN IN THE KIT. THE CUSTOMER FURTHER REPORTED THAT THE DAMAGE OCCURRED WITH THE SURGEON WAS LOADING A CAGE ON TO THE TIP AND THAT THE THREAD WHERE THE CAGE ATTACHES TO THE INSERTER TIP IS VERY THIN AND FRAGILE AND THE SURGEON SNAPPED THE THREAD WHILST LOADING THE CAGE. HE THEN WENT TO USE THE 6MM INSERTER TIP AND DID THE SAME THING AGAIN. THE SALES REPRESENTATIVE BELIEVES THAT THE SURGEON WAS CHECKING THE CAGE HAD BEEN LOADED CORRECTLY BY TRYING TO MOVE THE CAGE AND SNAPPED THE THREAD AGAIN. THE KIT HAS BEEN AT THE HOSPITAL FOR ABOUT 1 YEAR AND THIS SURGEON HAS USED THIS KIT MANY TIMES SO IS EXPERIENCED WITH IT. THE 6MM AND 7MM INSERTER TIPS ARE THE SIZES MOST COMMONLY USED IN THE SET AND THE SALES REPRESENTATIVE BELIEVES THAT THEY WERE IN FULL WORKING ORDER BEFORE THE CASE. THE SCRUB NURSE HAD MANAGED TO LOAD THE CAGE PERFECTLY BEFORE THE SURGEON DID. THERE WAS A SLIGHT DELAY IN SURGERY APPROX. 15MINS. THERE WAS A SPARE 6MM INSERTER ON THE SET WHICH WAS USED THAT TO COMPLETE THE SURGERY SUCCESSFULLY.. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5658148 ↗
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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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