Arthrex® AR-8835-50Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW TM,SS 3.5X 50MMCORT · Class 2 · Implant
Data updated Oct 16, 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 00888867047488), received between May 3, 2017 and May 3, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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
- Material Protrusion/Extrusion1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2017Material Protrusion/Extrusion
IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5068608): "PATIENT UNDERWENT A SURGICAL PROCEDURE IN 2016 OF ARTHROSCOPY LEFT KNEE AND OPEN MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION. DURING THE SURGERY AN IMPLANT DOCUMENTED AS ARTHREX NPFL IMPLANT SYSTEM WAS USED RELATED TO HER ANTERIOR TIBIAL TUBERCLEPLASTY AND PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH 2 SCREWS PLACED IN ORDER TO MAINTAIN THE GRAFT IN ITS MEDIAL POSITION. NO COMPLICATIONS WERE DOCUMENTED. IN 2017 DOCUMENTATION FROM THE ORTHOPEDIC SURGEON REVEALED THE PATIENT WAS IN FOR A FOLLOW UP AND WAS HAVING PAIN AND TENDERNESS RIGHT OVER HER TIBIAL TUBEROSITY TRANSFER. UPON X-RAY OF HER KNEE THE RESULTS REVEALED IN LATERAL VIEW SOME SLIGHT PROMINENCE OF ONE OF HER SCREWS THAT COULD CORRELATE WITH HER TENDERNESS. ON (B)(6) 2017 THE PATIENT PRESENTED TO THE HOSPITAL FOR SURGICAL PROCEDURE OF ARTHROSCOPY OF HER KNEE, SYNOVECTOMY AND REMOVAL OF DEEP IMPLANTS IN PROXIMAL TIBIA UNDER GENERAL ANESTHESIA. THE SURGEON DOCUMENTED THAT THE DISTAL MOST SCREW WAS IDENTIFIED BY PALPATION AND PATELLA TENDON SPLIT ALLOWED REMOVAL OF THAT SCREW WITHOUT DIFFICULTY. THE SECOND SCREW WAS IDENTIFIED MORE MEDIALLY AND ALSO REMOVED WITHOUT ANY DIF
Patient problems: Pain
MAUDE report 6540724 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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