HEALIX ADVANCE ORTHOCORD 222300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705021369), received between Jul 18, 2018 and Dec 26, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 26, 2018Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent; Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FORM THE AFFILIATE ON 01/11/2019 STATING THAT THE DATE OF THE EVENT WAS (B)(6) 2018. THE ADVERSE EVENT WAS THE IMPLANT PULLING OUT FROM THE BONE. THE AFFILIATE ALSO STATED THAT THE CASE WAS COMPLETED BY OPENING OTHER HEALIX STOCKS. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/15/2019 STATING THAT THE EXACT FAILURE THAT OCCURRED WAS A DEFORMED IMPLANT WHICH OCCURRED INTRA-OP. THIS EVENT CAUSED A 5 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM DUE TO THIS SURGICAL DELAY. THE CASE WAS COMPLETED BY OPENING ANOTHER IMPLANT WHICH WAS READILY AVAILABLE. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE AND NO DEBRIS WAS LEFT IN THE PATIENT BECAUSE THE DEVICE DID NOT BREAK INTO MORE THAN 2 PIECES.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 8196524 ↗
• MalfunctionDec 17, 2018Failure to Advance; Failure to Advance

  THIS IS REPORT 3 OF 5 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT FIVE ANCHOR DEVICES COULD NOT BE IMPLANTED INTO THE PATIENT'S BONE. ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER SEVERAL ATTEMPTS. IT WAS FURTHER REPORTED THAT THE BONE QUALITY WAS NOT SUFFICIENT TO IMPLANT THE ANCHORS. THERE WAS AN UNSPECIFIED DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON USED ANOTHER TECHNIQUE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8169111 ↗
• MalfunctionJul 18, 2018Positioning Failure; Positioning Failure

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT AFTER THE ANCHOR WAS INSERTED, AS THE SURGEON REMOVED THE INSERTER HANDLE, THE SUTURES WERE CAUGHT IN THE HANDLE AND DE-THREADED THE ANCHOR. THE ANCHOR WAS REMOVED AND DISCARDED. A LARGER ANCHOR WAS INSERTED IN THE SAME HOLE. AFTER THIS REPLACEMENT ANCHOR WAS INSERTED AND HANDLE REMOVED, THERE WAS A GOOEY SUBSTANCE HOLDING THE FOUR FREE ENDS OF THE SUTURES TOGETHER. SURGEON HAD TO CUT THE ENDS OF THE SUTURE TO RELEASE THEM AND CONTINUED WITH THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 15-MINUTE DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7698236 ↗