Arthrex® AR-8835CL-10Recalls & reported problems
Arthrex, Inc. · KreuLock Compression Screw, SS, 3.5x10mm · Class 2 · Implant
Data updated Oct 18, 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 00888867323032), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6) 2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBIL
Patient problems: Foreign Body Reaction
MAUDE report 21322653 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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