XTENDOBUTTON 71935602Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556702703), received between May 28, 2020 and Jul 13, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "SQUEAKING KNEE IS A RARE COMPLICATION OF ACL SURGERY", 1 PATIENTS HAD ¿SQUEAKING NOISE COMING FROM HER KNEE WITH FLEXION AND EXTENSION MOVEMENTS.¿ 8 MONTHS AFTER A "LEFT ACL RECONSTRUCTION" PROCEDURE USING ONE (1) XTENDOBUTTON DEVICE. THE EVENT WAS RESOLVED WITH A REVISION SURGERY THAT REMOVED SOME LOOSE FIBER LOOP SUTURE PROTRUDING THROUGH THE TIBIAL TUNNEL AND INTO THE MEDIAL COMPARTMENT. PATIENT SQUEAKING SOUND COMPLETELY RESOLVED AFTER THE SURGERY WITHOUT PAIN OR INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 17320048 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: XTENDOBUTTON, CLINICAL STUDY: PMCF.2018.12, SUBJECT ID: 12.006, AE#01: DVT. IT WAS REPORTED THAT AFTER A ACL SURGERY PERFORMED ON 2/10/2019 WITH XTENDOBUTTON ROUND MD17 DIA 7.5 PEG AND ULTRABUTTON ADJUSTABLE FIXATION DEVICE, THE PATIENT DEVELOPED THROMBUS IN ONE OF THE POSTERIOR TIBIAL VEINS FROM 10 TO 5CM BELOW THE KNEE CREASE, BOTH PERONEAL VEINS FROM 20 TO 10CM BELOW THE KNEE CREASE, AND SOLEAL VEIN FROM 22 TO 6 CM BELOW THE KNEE CREASE AND PHASIC FLOW WAS SEEN IN THE POPLITEAL VEIN AND ABOVE IDENTIFIED ON 10/10/2019. THEN ON 18/10/2019 THERE WAS AN IMPROVEMENT IN THE VENOUS THROMBOSIS OF THE SOLEAL AND POSTERIOR TIBIAL VEINS, BUT THE THROMBUS STILL PERSISTED IN THE SOLEAL VEIN. THEN ON 13/11/2019 THERE WAS NOTICED A SHORT SEGMENT THROMBUS IN ONE OF 2 POSTERIOR TIBIAL VEINS BUT THIS WAS A MILD IMPROVEMENT OF THE CALF DVT, THERE WAS NO DETERIORATION OR PROXIMAL PROPAGATION. THE CONDITION WAS TREATED WITH MEDICATION(APIXABAN AND ASPIRIN), THERAPY AND REST. THE PATIENT HAS BEING RECOVERED AND ITS NOW WAITING ANOTHER MONITORING VISIT ON 27-28 OF APRIL 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPOR

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11617206 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT HAD A MEDICAL INTERVENTION (ARTHROSCOPIC DEBRIMENT) DUE TO RE-RUPTURE OF GRAFT. THE OUTCOME OF THE PATIENT IS STILL RECOVERING. NO DEVICES WERE REMOVED DURING THE PROCEDURE. NO OTHER COMPLICATIONS OR DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 10574810 ↗
• InjurySep 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN ALC WITH XTENDOBUTTON, THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS. THE CONDITION WAS TREATED WITH MEDICATION (XARELTO 15 MG AND APIXABAN) TWICE PER DAY VIA ORAL. THE PATIENT RECOVERED SUCCESSFULLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Thrombosis

  MAUDE report 10544865 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SUBJECT HAD AN ACL TEAR THAT WAS REPAIRED USING THE XTENDOBUTTON, BACK IN (B)(6) 2019. LATER ON, THE PATIENT PRESENTED AN INFECTION WHICH WAS TREATED WITH ARTHROSCOPIC WASHOUT AND SYNOVECTOMY AS WELL AS ANTIBIOTIC THERAPY VIA PICC LINE; THE DEVICE REMAINED IN SITU. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10099580 ↗