HEALIX ADVANCE ORTHOCORD 222298Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 10886705021345), received between Jun 22, 2018 and Aug 28, 2026 — classified as 18 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Break” (65 reports).

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 25 most recent of 116 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503333 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439133 ↗
• MalfunctionAug 25, 2026Break

  It was reported that during a Rotator Cuff Repair surgery, the HEALIX ADVANCE ORTHOCORD device suture broke off when tightened. The user changed to another one to continue the surgery, the same problem happened again. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438960 ↗
• MalfunctionMar 11, 2026Packaging Problem

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE HAD A NON-CONFORMITY BETWEEN THE OUTER LABELING AND THE DEVICE CONTAINED IN THE BOX. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568729 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE, THE SURGEON OPENED THE BONE FORAMEN WITH AN AWL AND TAP AND AWL TO INSERT THE HEALIX IN QUESTION MEDIAL AS USUAL AND INSERTED THE IMPLANT. HOWEVER, THE MOMENT THE TIP OF THE IMPLANT WAS INSERTED INTO THE BONE FORAMEN AND TURNED. THE IMPLANT BROKE FROM THE CENTER. THE FRAGMENTS WERE IDENTIFIED UNDER ARTHROSCOPIC OBSERVATION, AND THE BROKEN IMPLANT WAS REMOVED FROM THE BODY. THE SURGEON RECHECKED THE BONE FORAMEN AND INSERTED ANOTHER IMPLANT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223994 ↗
• MalfunctionJan 27, 2026Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, WHILE USING THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE, AFTER THE SURGEON INSERTED THE ANCHOR INTO THE BONE FORAMEN, ONE OF THE SUTURES SLIPPED OUT WHEN HE PULLED OUT THE INSERTER. IT WAS REPORTED THAT NO SUTURES WERE LEFT INSIDE THE BODY. IT WAS REPORTED THAT THE SURGEON REPAIRED THE ROTATOR CUFF USING THE TWO REMAINING SUTURES THAT WERE IN THE HEALIX DEVICE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192374 ↗
• InjuryJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC BANKART AND REMPLISSAGE SURGERY, IT WAS OBSERVED THAT WHILE USING THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE, THE INSERTER BROKE WHILE INSERTING THE ANCHOR FOR THE REMPLISSAGE. ACCORDING TO THE REPORTER, THE WOUND WAS OPENED AND THE INCISION WAS LENGTHENED IN ORDER TO REMOVE THE REMAINS OF THE INSERTER. IT WAS REPORTED THAT THIS SUCCEEDED BUT THE REMPLISSAGE COULD NOT BE FINISHED BECAUSE OF TOO MUCH SWELLING OF THE SHOULDER. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 22513230 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR BROKE OFF. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353006 ↗
• MalfunctionMar 10, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON SHOULDER, THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE WAS BEING USED WHEN THE SURGEON CREATED A BONE HOLE AND INSERTED THE ANCHOR IN QUESTION, BUT THE ANCHOR BROKE. ALL BROKEN ANCHORS WERE RETRIEVED. THE SURGEON FIRMLY CUT THE TAP, INSERTED A NEW ANCHOR, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO INJURIES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558372 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929240 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED FROM JAPAN THAT DURING AN ¿ORCR¿ OPEN ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE WAS BROKEN DURING INSERTION. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19721033 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON ATTEMPTED TO INSERT THE TWO SUTURES OF THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE THROUGH THE VERSALOK AND INTO THE BONE, ONE SUTURE IN THE VERSALOK BROKE WITH A SLIGHT PULL TO THE HAND. ACCORDING TO THE REPORTER THE SURGEON WAS CONCERNED AND PULLED THE OTHER THREAD SLIGHTLY AND THEN IT ALSO BROKE. ANOTHER DEVICE WAS DEPLOYED AT ANOTHER LOCATION, AND THE SAME VERSALOK WAS USED. ACCORDING TO THE REPORTER, ALTHOUGH IT FELT TIGHT AGAINST THE BONE HOLE, THERE WERE NO PROBLEMS DURING INSERTION. A MITEK PASSER WAS USED TO THREAD THE ROTATOR CUFF, AND THERE WERE NO PROBLEMS. THERE WERE ALSO NO PROBLEMS WHEN THREADING THE VERSALOK. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653253 ↗
• MalfunctionJun 24, 2024Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE BR3SUT W/OC AND 5.5 HEALIX ADVANCE BR W/OCORD DEVICE ANCHORS WERE BROKEN OFF, REMOVED ALL BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594612 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521821 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE PERFORMED SIX MONTHS AGO ON AN UNKNOWN DATE, A 5.5 HEALIX ADVANCE BR3SUT W/OC WAS USED. ACCORDING TO THE REPORT, AFTER SURGERY, THE PATIENT SUSPECTED OF BEING INFECTED. IT WAS REPORTED THAT THE SUSPECTED INFECTION WAS DISCOVERED THROUGH AN MRI THAT SHOWED THAT THE AREA WHERE THE HEALIX USED WAS WHITE. IT WAS REPORTED THAT THE HOSPITAL WAS CURRENTLY CONFIRMING THE INFECTION. IT WAS REPORTED THAT ALTHOUGH THERE WERE NO BACTERIA, THERE WERE WHITE BLOOD CELLS. IT WAS REPORTED THAT THE PATIENT¿S SYMPTOMS WERE NOT SIGNIFICANT, AND THE CRP READING WAS ABOUT 1.7. IT WAS REPORTED THAT ABOUT 1CC OF JELLY-LIKE SUBSTANCE CAME OUT. IT WAS REPORTED THAT IT WAS UNCLEAR WHETHER THIS SUBSTANCE WAS CAUSED BY INFECTION OR BY AN ABSORPTION OF THE ANCHOR. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 19476565 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE HUMERUS SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS OF THE DEVICE WERE REMOVED. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380321 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE TIP/BRIDGE WAS BROKEN AFTER THE IMPLANT RELEASED ALL OF THE SUTURES. A NEW PEEK ANCHOR WAS IMPLANTED IN PLACE OF THE BROKEN ONE AND ALL SUTURES HAD TO BE REPASS. THE USER TAPPED OVER THE OLD ANCHOR AND PUT IN A NEW DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034513 ↗
• MalfunctionMar 15, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18911733 ↗
• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A LABRAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN TIGHTENING THE 5.5 HEALIX ADVANCE BR3SUT W/OC SUTURE DEVICE, THE SUTURE BROKE OFF. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18856749 ↗
• MalfunctionFeb 28, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE (X2) 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICES ANCHOR WAS INSERTED INTO THE BURR HOLE. THE ANCHOR IN QUESTION WENT IN SMOOTHLY UP TO THE CANCELLOUS BONE THREAD; HOWEVER, THE ANCHOR IN QUESTION DID NOT GO IN AT THE CORTICAL BONE THREAD. THE THREAD GOT STRIPPED, AND THE ANCHOR IN QUESTION COULD NOT BE USED FOR SURGERY. ALTHOUGH A NEW ANCHOR WITH SAME SIZE WAS USED, SAME ISSUE OCCURRED AGAIN. THE SECOND ANCHOR COULD NOT BE USED. THEN, THE SUTURE OF THE ANCHOR WAS USED FOR SUTURING OF THE INJURED AREA. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800601 ↗
• MalfunctionFeb 28, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE (X2) 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICES ANCHOR WAS INSERTED INTO THE BURR HOLE. THE ANCHOR IN QUESTION WENT IN SMOOTHLY UP TO THE CANCELLOUS BONE THREAD; HOWEVER, THE ANCHOR IN QUESTION DID NOT GO IN AT THE CORTICAL BONE THREAD. THE THREAD GOT STRIPPED, AND THE ANCHOR IN QUESTION COULD NOT BE USED FOR SURGERY. ALTHOUGH A NEW ANCHOR WITH SAME SIZE WAS USED, SAME ISSUE OCCURRED AGAIN. THE SECOND ANCHOR COULD NOT BE USED. THEN, THE SUTURE OF THE ANCHOR WAS USED FOR SUTURING OF THE INJURED AREA. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800597 ↗
• MalfunctionFeb 20, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX ADVANCE BR3SUT W/OC DEVICE ANCHOR SUTURE FOR INTERNAL SIDE SNAPPED. STINGER WAS USED FOR SUTURE HOOKING DEVICE. THE BLADE TIP HIT THE SUTURE SEVERAL TIMES DURING THE SUTURE HOOKING BECAUSE OF POOR FIELD OF VIEW. THE ORTHOCORD WAS WAVY AND BROKE DURING KNOT TYING. ONE OUT OF THE THREE HOOKING SUTURES BROKE. A NON MITEK PRODUCT WAS INSERTED, AND TWO SUTURES WERE ADDED NEAR WHERE THE BROKEN SUTURE WAS HANGING. THE SUTURE WAS HOOKED, AND THEN, KNOT TYING WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WAS NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741752 ↗
• MalfunctionDec 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP IN TAIWAN THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON 11/17/23 THE 5.5 HEALIX ADVANCE BR3SUT W/OC SUTURE WAS DIVIDING APART AND IT WAS DECOMPOSED AUTOMATICALLY WHEN THE SURGEON STARTED TO TIGHTEN THE ANCHOR SUTURE. IT WAS REPORTED THAT THE WEAKENED SUTURE WAS REINFORCED WITHIN THE OUTSIDE ANCHOR SUTURE. ALL BROKEN PARTS WERE REMOVED. THERE WAS A SURGERY DELAY OF 20 MINUTES REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277506 ↗
• MalfunctionNov 7, 2023Crack; Crack

  IT WAS REPORTED BY THE SALES REP IN TAIWAN THAT DURING AN UNKNOWN PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC THREAD WAS SERIOUSLY BROKEN, AND THERE WERE NO SPECIAL CONDITIONS IN USE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083568 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN TAIWAN THAT DURING AN UNKNOWN PROCEDURE IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE BR3SUT W/OC THREAD WAS BROKEN AND THE KNOT COULD NOT BE TIED. IT WAS REPORTED THAT THE THREAD WAS FRAGILE AND THERE WAS NO SOLID BODY TO PROVIDE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083453 ↗