GRAFTMAX KS-ALBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854042229), received between Mar 19, 2019 and Jun 16, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE KS-ALB, GRAFTMAX ADJUSTABLE LOOP BUTTON, WAS USED IN AN ACL RECONSTRUCTION WITH HAMSTRING GRAFT ON (B)(6) 2020. THE PLATE (BUTTON) BECAME DISLODGED FROM THE BONE WHEN PULLING THE THREADS (SUTURES) TO RAISE THE GRAFT. THE THREADS (SUTURES) BROKE THE PLATE (BUTTON) AND THE BUTTON MIGRATED TO THE THIGH MUSCLE. THE DOCTOR ATTEMPTED TO RETRIEVE THE BUTTON BUT WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED USING AN INTERFERENCE SCREW, BRAND UNKNOWN. THERE WAS A 40-MINUTE DELAY. ALTHOUGH THE PATIENT IS FINE AND THERE IS NO REPORTED INJURY OR INDICATION ANOTHER SURGERY WILL BE REQUIRED TO REMOVE THE PLATE(BUTTON) THIS IS CONSIDERED AN INJURY FOR CONMED. THIS REPORT IS BEING RAISED DUE TO PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10157319 ↗
• InjuryMar 19, 2019Osseointegration Problem; Patient Device Interaction Problem; Osseointegration Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THE KS-ALB, GRAFTMAX BUTTON FAILED DURING AN ACL REPAIR ON (B)(6) 2019. AFTER THE PATIENT TOOK HER FIRST STEPS, THERE WAS A "SNAP" AND SHE LOST HER BALANCE. THE PATIENT REMAINED IN THE HOSPITAL UNTIL HER REVISION ACL REPAIR ON (B)(6) 2019. IT WAS DETERMINED THAT THE LOCKING MECHANISM SLIPPED OPEN. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER OF THE SAME GRAFTMAX BUTTONS. THIS REPORT IS BEING RAISED BASED ON PATIENT INJURY AND REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8434500 ↗