HEALIX ADVANCE 222424Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10886705030590), received between Jan 15, 2020 and Sep 29, 2026 — classified as 7 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that during an arthroscopic rotator cuff repair procedure the 5.5MM HEALX ADV SP BIOC ANCHOR device broke and could no longer be used. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930918 ↗
• MalfunctionSep 10, 2026Break; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715737 ↗
• MalfunctionSep 1, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549721 ↗
• MalfunctionSep 1, 2026Detachment of Device or Device Component

  It was reported that during an Arthroscopic Rotator Cuff Repair (ARCR) for a shoulder surgery following ASD, two Helix anchors devices pre-loaded with Permatape were inserted medially and sutures were passed through the rotator cuff. When the surgeon tried to pass the medial anchor sutures through the HASP 5.5 bridge anchor pulling the suture kite caused it to detach from the anchor. As the suture kite could not be reattached, a new anchor was used to continue the surgery; it functioned without issue. 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 50545001 ↗
• MalfunctionAug 26, 2026Break

  It was reported that during an Arthroscopic Rotator Cuff Repair (ARCR) surgery, while using the 5.5MM HEALX ADV SP BIOC ANCHOR device when the suture was being threaded through the anchor with a needle threader, the wire of needle threader snapped. 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 50452348 ↗
• MalfunctionJun 10, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION FOR ROTATOR CUFF TEAR, THE HEALIX ADVANCE WAS USED ACCORDING TO THE PROCEDURE MANUAL, BUT THE ANCHOR WAS NOT FIXED AND DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF UNDER 30 MINUTES AND NO HARM TO THE PATIENT. IT WAS CONFIRMED THAT THERE WERE NO REMAINING IMPLANTS IN THE BODY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460250 ↗
• MalfunctionJun 9, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR FOR A ROTATOR CUFF TEAR, THE HEALIX ADVANCE WAS USED ACCORDING TO THE PROCEDURE MANUAL, BUT THE ANCHOR WAS NOT FIXED AND DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS SURGICAL DELAY OF UNDER 30 MINUTES AND NO HARM TO THE PATIENT. IT WAS CONFIRMED THAT THERE WERE NO REMAINING IMPLANTS IN THE BODY. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25447969 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). POST MARKET COMPLICATION RECEIVED FOR RE-TEARS OR NEW TEARS (LEFT KNEE DISPLACED BUCKET HANDLE MEDIAL MENISCUS TEAR). DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2023 (LEFT ACL TEAR, MEDIAL MENISCUS TEAR, LATERAL MENISCUS TEAR). DATE OF REOPERATION/REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RE-OPERATION WITH NO IMPLANT REMOVED/IMPLANTED DEPUY SYNTHES PRODUCTS USED: RGDLOOP ADJUSTABLE LONG: CATALOG NUMBER: 232448. LOT NUMBER: 8L67308. DEPUY SYNTHES PRODUCTS USED: TRUESPAN 12 DEGREE PEEK: CATALOG NUMBER: 228151. LOT NUMBER: 9L71051. DEPUY SYNTHES PRODUCTS USED: INTRAFIX ADVANCE 10X23 SCREW & LARGE 23MM SHEATH. CATALOG NUMBER: 254803. LOT NUMBER: 9L62950. DEPUY SYNTHES PRODUCTS USED: 5.5MM HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR. CATALOG NUMBER:222424. LOT NUMBER: 116L683. REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25301070 ↗
• MalfunctionMay 26, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE, AFTER THE SURGEON PLACED A THIRD-PARTY ANCHOR MEDIALLY, AND A 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE WAS UTILIZED TO SUTURE THE ROTATOR CUFF AND CREATE A BRIDGING CONSTRUCT. IT WAS REPORTED THAT THE BONE TUNNEL, WHICH WAS CREATED USING A SELF-PUNCH, WAS SITUATED TOO CLOSE TO THE APEX OF THE GREATER TUBEROSITY; FURTHERMORE, ITS TRAJECTORY WAS SLIGHTLY SUBOPTIMAL. CONSEQUENTLY, IT WAS DETERMINED THAT ADEQUATE FIXATION COULD NOT BE ACHIEVED EVEN WITH PARTIAL ANCHOR INSERTION. AS A RESULT, THE DECISION WAS MADE TO ABANDON THE ANCHOR INSERTION ATTEMPT AND WITHDRAW THE ANCHOR THAT HAD ALREADY BEEN PARTIALLY INSERTED. IT WAS REPORTED THAT THERE WAS A CONCERN THAT WITHDRAWING THE DILATOR WOULD CAUSE THE BONE TUNNEL TO ENLARGE; THEREFORE, THE DILATOR WAS UNAVOIDABLY LEFT IN PLACE WITHIN THE BONE TUNNEL. A NEW ANCHOR DEVICE WAS RETRIEVED AND UTILIZED, WITH THE ANCHOR PLACEMENT SITE ADJUSTED TO A MORE DISTAL POSITION. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25284012 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE HEALIX ADVANCE DEVICE BROKE DURING SELF-PUNCH INSERTION OF THE IMPLANT. THE SURGEON IMMEDIATELY STOPPED USING IT, OPENED A NEW PRODUCT, AND SUCCESSFULLY PLACED THE IMPLANT. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25278787 ↗
• MalfunctionMay 26, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON USED THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE ACCORDING TO THE INSTRUCTIONS BUT WAS UNABLE TO IMPLANT IT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 25277659 ↗
• MalfunctionMay 5, 2026Migration

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGERY, THE 5.5 MM HEALX ADV SP BIOC ANCHOR DISLODGED DUE TO THE PATIENT'S LOOSE BONE STRUCTURE. THE SURGERY WAS THEN COMPLETED USING HAK6.5. NO FRAGMENT REMNANTS WERE FOUND IN THE BODY. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086427 ↗
• MalfunctionApr 23, 2026Unintended Movement

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE 5.5MM HEALX ADV SP BIOC ANCHOR CAME LOOSE, DESPITE BEING PROPERLY INSERTED. THE BONE QUALITY WAS GOOD, AND THE REASON FOR THE LOOSENING IS UNKNOWN. THERE WERE NO RETAINED TISSUE FRAGMENTS. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT ANCHOR. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971176 ↗
• MalfunctionApr 20, 2026Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PILOT HOLE WAS CREATED USING AN AWL. THE ANCHORS ON BOTH 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES BROKE. THE SURGEON CONFIRMED NO IMPACT ON THE PATIENT AND THAT NO RESIDUE REMAINED IN THE BODY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 24925781 ↗
• MalfunctionApr 20, 2026Break

  THIS IS REPORT 2 OF 2 FOR (B)(4) IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PILOT HOLE WAS CREATED USING AN AWL. THE ANCHORS ON BOTH 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES BROKE. THE SURGEON CONFIRMED NO IMPACT ON THE PATIENT AND THAT NO RESIDUE REMAINED IN THE BODY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 24925779 ↗
• MalfunctionApr 8, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) PROCEDURE, THE SURGEON TRIED TO INSERT THE 5.5MM HEALX ADV SP BIOC ANCHOR, BUT IT WOULDN'T GO IN. UPON REMOVING IT FROM THE BODY, IT WAS FOUND THAT THE TIP OF THE 5.5MM HEALX ADV SP BIOC ANCHOR SHAFT WAS BENT FROM THE ANCHOR. ANOTHER 5.5MM HEALX ADV SP BIOC ANCHOR WAS USED, AND THE OPERATION WAS COMPLETED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820321 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE HEALIX ADVANCE DEVICE DESPITE CREATING A PILOT HOLE WITH OWL TAP DUE TO THE APPARENT HARDNESS OF THE BONE, THE DEVICE BROKE DURING INSERTION INTO THE BONE TUNNEL. ANOTHER LIKE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698601 ↗
• MalfunctionMar 25, 2026Break; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE WAS USED AS THE LATERAL ANCHOR. EIGHT ORTHOCORDS WERE INSERTED FROM THE MEDIAL ANCHOR, AND AS THE FIRST LATERAL ANCHOR FOR THE BRIDGE WAS INSERTED AFTER DRILLING A PILOT HOLE WITH A HEALIX PURPLE AWL, IT SLIPPED MIDWAY THROUGH INSERTION. THEN ABOUT THE SECOND THREAD OF THE ANCHOR BROKE OFF INSIDE THE BONE TUNNEL AND CAME OUT. AFTER THAT, ANOTHER HASP5.5 WAS USED A LITTLE FURTHER DISTAL, AND THEN A HAK6.5 WAS USED IN THE ORIGINAL HOLE AT A DIFFERENT ANGLE. THE SURGEON SAID THAT SOME PIECES MIGHT HAVE REMAINED INSIDE THE BONE TUNNEL. MOST OF THEM WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A SURGICAL DELAY WITHIN THIRTY MINUTES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24690992 ↗
• MalfunctionFeb 12, 2026Crack

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED. WHEN AN ATTEMPT WAS MADE TO THREAD A SUTURE THROUGH THE 5.5MM HEALX ADV SP BIOC ANCHOR, IT WAS CONFIRMED THAT THE IMPLANT HAD CRACKED. THEREFORE, THE PRODUCT WAS NOT USED. A NEW PRODUCT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321299 ↗
• MalfunctionFeb 9, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4.9MM HEALX ADV SP BIOC ANCHOR AND THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES WERE BEING USED WHEN BUT WAS UNABLE TO SECURE IT INTO THE BONE AND THEY FELL OUT. THE SURGERY WAS COMPLETED USING A DIFFERENT PRODUCT. THERE WERE NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293857 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, ON RIGHT SHOULDER FOR ROTATOR CUFF TEAR PERFORMED, THE TWO (X2) 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES WERE BEING USED ACCORDING TO THE SURGICAL MANUAL, BUT THE ANCHOR BROKE AND COULD NOT BE USED. THE NEW PRODUCT WAS OPENED AND INSERTED IN A DIFFERENT LOCATION AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO PIECES LEFT IN THE BODY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830189 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT THIS WAS AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, ON RIGHT SHOULDER FOR ROTATOR CUFF TEAR PERFORMED, THE TWO (X2) 5.5MM HEALX ADV SP BIOC ANCHOR DEVICES WERE BEING USED ACCORDING TO THE SURGICAL MANUAL, BUT THE ANCHOR BROKE AND COULD NOT BE USED. THE NEW PRODUCT WAS OPENED AND INSERTED IN A DIFFERENT LOCATION AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO PIECES LEFT IN THE BODY AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830187 ↗
• MalfunctionNov 24, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY FOR SHOULDER ROTATOR CUFF TEAR, IT WAS OBSERVED THAT THE SURGEON INSERTED THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE THE WRONG DIRECTION, SO HE REINSERTED IT. IT WAS REPORTED THAT AT THAT TIME, THE DILATOR TIP AT THE TIP CAME OFF THE MAIN BODY AND COULD NOT BE USED. 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 23630090 ↗
• MalfunctionNov 18, 2025Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT THIS WAS AN UNSPECIFIED SURGICAL PROCEDURE, THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE WAS BEING USED WHEN IT WAS REPORTED THAT IN THIS CASE THERE WAS SEVERE SYNOVIAL PROLIFERATION, AND THERE WERE MANY OCCASIONS WHEN IT WAS DIFFICULT TO MAINTAIN VISUAL FIELD. THE SURGEON THREADED THE SUTURE OF THE MEDIAL ANCHOR THROUGH THE ANCHOR IN QUESTION AND STRUCK IT WITH A HAMMER. HOWEVER, IT WAS OVERLOOKED THAT THE SUTURE HAD NOT BEEN PROPERLY THREADED THROUGH THE ANCHOR IN QUESTION AND HAD BECOME TANGLED AROUND IT. THE SURGEON HAMMERED THE ANCHOR IN QUESTION IN DEEPLY AS IT WAS AND ATTEMPTED TO INSERT IT, BUT THE ANCHOR BROKE, POSSIBLY DUE TO THE STRESS PLACED ON IT. THE SURGEON IMMEDIATELY STOPPED THE INSERTION AND REMOVED THE ANCHOR. THE NEW PRODUCT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585760 ↗
• MalfunctionNov 5, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON'S ATTEMPT TO THREAD THREE SUTURES THROUGH THE DOUBLE KITE, THE 5.5MM HEALX ADV SP BIOC ANCHOR DEVICE CRACKED EASILY. IT WAS REPORTED THAT THE DEVICE WAS DISCONTINUED, BUT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 23479947 ↗