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Arthrex® AR-9562-20NLRecalls & reported problems

Arthrex, Inc. · 4.5x20mm Peripheral Screw, NON-LOCKING · 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 00888867296657), received between Nov 18, 2020 and Nov 18, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

Most reported problems

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth1

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.

  • InjuryNov 18, 2020Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PATIENT HAD UNDERGONE A SHOULDER PROCEDURE (B)(6) 2020. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED AT THE TIME OF ORIGINAL SURGERY: PART NUMBER LOT NUMBER AR-9560-24-2, 7266; AR-9561-20P, 7181; AR-9562-20NL, 2018001453; AR-9562-24NL, 2019001012; AR-9563-16, 2019004170; AR-9563-16, 2019003483; AR-9564-2436-LAT, 19.03388. THE PATIENT IS SCHEDULED TO HAVE A SECOND SURGERY (B)(6) 2020. UPDATED INFORMATION PROVIDED (B)(6) 2020: THE PATIENT BEGAN EXPERIENCING PAIN APPROXIMATELY 4 WEEKS PRIOR TO THE REPORT TO ARTHREX. SERIAL X-RAYS DIAGNOSED GLENOID BASEPLATE LOOSENING. THE REVISION SURGERY TOOK PLACE (B)(6) 2020 AS SCHEDULED. DURING THE REVISION SURGERY ALL ORIGINAL ARTHREX PRODUCTS, LISTED IN THE INITIAL REPORT, WERE EXPLANTED. ONCE THE BASEPLATE WAS REMOVED, ANOTHER MANUFACTURER'S BASEPLATE, PERIPHERAL SCREWS AND GLENOSPHERE WERE IMPLANTED. SEVERAL CULTURE WERE TAKEN AND SENT FOR RAPID TEST TO THE LAB. RAPID TEST RESULTS RETURNED INDICATING LESS THAN 1 NEUTROPHIL. ARTHREX SALES REP WHO WAS PRESENT STATES THE SURGEON DID VOICE CONCERN OF THE LACK OF BONY INGROWTH ON THE BACKSIDE OF THE BASEPLATE. UPDATED INFORMATION PROVIDED

    Patient problems: Pain

    MAUDE report 10861673 ↗

Other shoulder prosthesis, reverse configuration devices

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Sources and updates

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