VARIAX 628535SRecalls & reported problems
Stryker GmbH · Hook Plate · Class 2 · Implant
All models of VARIAX (345)
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 07613327085440), received between Sep 28, 2020 and Sep 28, 2020 — 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
- Positioning Failure1
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.
MalfunctionSep 28, 2020Break; Positioning Failure; Break; Positioning Failure
AS REPORTED: "[EVENT DETAILS] WHEN THE CLAVICLE HOOK PLATE WAS OPERATED, THE LOCKING SCREW DID NOT LOCK IN THE LOCKING HOLE. PLATE USED: 628535S LOCATION OF DEFECTIVE LOCK: FRONT SIDE OF THE PLATE'S MOST DISTAL HOLE OCCURRENCE STATUS: INSERT 3 SCREWS AFTER SETTING THE PLATE ((1) ELLIPTICAL HOLE: NON-LOCKING, (2) ROUND HOLE NEXT TO THE ELLIPSE DISTAL SIDE: ROCKING, (4) FAR-MOST REAR CIRCULAR HOLE: ROCKING). A PHENOMENON THAT THE LOCKING SCREW DOES NOT LOCK WHEN THE LOCKING SCREW IS INSERTED 18MM INTO THE 4TH MOST DISTAL LOCKING HOLE. SET IT THERE AND INSERT THE LOCKING SCREW INTO THE MOST RECENT HOLE (LOCK WITHOUT ANY PROBLEM). I TRIED THE FOLLOWING FOR HOLES THAT DID NOT LOCK AGAIN. CHECK THE DRILLING DIRECTION NO PROBLEM (THE GUIDE SLEEVE WAS WITHIN THE SWING RANGE). CONFIRMATION OF PLATE LIP AND SCREW HEAD NO INTERSTITIAL TISSUE SUCH AS SOFT TISSUE CAN BE CONFIRMED ON THE LIP. AS FAR AS I COULD SEE THE SCREW HEAD, IT SEEMED TO BE NO PROBLEM. CHANGE THE DRILL DIRECTION AND INSERT ANOTHER LOCKING SCREW 16 MM AGAIN, BUT IT DOES NOT LOCK. FINALLY, AT THE DISCRETION OF DR., IT ENDS WITHOUT INSERTING A SCREW INTO THE HOLE." "THE PLATE IS CURRENTLY INSIDE THE PATIENT'S BODY." ADDITIONAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10597517 ↗
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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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