BIOINTRAFIX 254629Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10886705013258), received between Jun 30, 2018 and May 20, 2026 — classified as 7 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Break” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE TAIL OF THE BIOINTRAFIX WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228271 ↗
• MalfunctionJan 9, 2026Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (ACL) PROCEDURE, IT WAS DISCOVERED THAT TWO BIOINTRAFIX DEVICES BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED 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 24020526 ↗
• InjuryDec 11, 2025Migration; Migration

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT FOUR MONTHS AFTER THE INITIAL AUTOGRAFTING OF THE ANTERIOR CRUCIATE LIGAMENT SURGERY PERFORMED ON (B)(6) 2025, USING BIOINTRAFIX TBIAL SH SM 30MM AND BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICES, THE PATIENT NOTED A COSMETIC DEFECT IN THE PROJECTION OF THE SCREW ON THE TIBIA. IT WAS REPORTED THAT THERE WAS NO PAIN UPON PALPATION, BUT A HARD OBJECT WAS FELT IN THE PROJECTION OF THE SUTURE ON THE TIBIA. ACCORDING TO THE REPORTER, AN MRI WAS PERFORMED ON (B)(6) 2025 OF THE LEFT KNEE JOINT - SCREW MIGRATION FROM THE TIBIAL CANAL WHICH REQUIRED A REVISION SURGERY FOR REMOVAL, HOWEVER THE INTEGRITY OF THE ANTERIOR CRUCIATE LIGAMENT GRAFT WAS INTACT. IT WAS REPORTED THAT THERE WAS NO SOFT TISSUE REACTION OR INFLAMMATION NOTED AND THE PATIENT'S CURRENT CONDITION IS SATISFACTORY, WITH FUTURE MANAGEMENT NOTES AS REHABILITATION AND OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23782902 ↗
• MalfunctionAug 13, 2025Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, IT WAS OBSERVED THAT WHILE USING THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE AND THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE. IT WAS OBSERVED THAT THE ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792068 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BIOINTRAFIX TIBIAL SH SM 30MM SHEATH DEVICE BROKE OFF. IT WAS REPORTED THAT ALL BROKEN PARTS OF THE DEVICE WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365051 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE WAS BROKEN. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104142 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE BIOINTFX 6-8MMX30MM TPR SCR 2ND AND BIOINTRAFIX TBIAL SH SM 30MM DEVICES WERE BEING USED WHEN THE IMPLANT BROKE AT THE TIP AS THE DOCTOR WAS ABOUT TO USE. IT IS UNKNOWN WHETHER ANOTHER 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732978 ↗
• MalfunctionFeb 28, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE THE 2X BIOINTRAFIX TBIAL SH SM DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 21496348 ↗
• MalfunctionFeb 28, 2025Break; Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE THE 2X BIOINTRAFIX TBIAL SH SM DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21496200 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028174 ↗
• MalfunctionJul 11, 2024Break; Break

  EVENT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2024 WHILE USING THE BIO-INTRAFIX TAPERED SCREW DEVICE AND BIOINTRAFIX TBIAL SH SM 30MM DEVICE THE SHEATH BROKE AND THE ANCHOR AND SHEATH WERE NOT SUCCESSFULLY IMPLANTED TOGETHER. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718783 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTRAFIX TBIAL SH DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846570 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON 11/24/23 THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE SLIPPED DURING THE SURGERY AND COULDN'T BE TIGHTENED. AFTER REPEATED TIGHTENING ATTEMPTS, THE WOUND WAS CLOSED AND CLOSED THE SURGERY. POST OP, LAXITY WAS NOTED IN POST-OPERATIVE PHYSICAL EXAMINATION. RADIOGRAPHIC EXAMINATION REVEALED THAT THE RIGIDLOOP ADJUSTABLE IMPLANT WAS POSITIONED IN THE MUSCLE LAYER AND FAILED SURGICAL FIXATION. PATIENT UNDERWENT AN ACL REVISION PROCEDURE. THE PATIENT WAS IN STABLE CONDITION NOW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18310443 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT THE BIOINTFX 6-8MMX30MM TPR SCR 2ND ANCHOR WAS BROKEN OFF, AND THE BIOINTRAFIX TBIAL SH SM 30MM SHEATH PRODUCT WAS TORN AT THE HEAD END AND FOUR RIDGES WERE SCATTERED, MAKING IT IMPOSSIBLE TO ACHIEVE TENDON FIXATION. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100819 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2022, TWO BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICES WERE USED. ACCORDING TO THE REPORT, DURING THE CONTROL EXAMINATION 12 MONTHS AFTER THE OPERATION, NO PATHOLOGY WAS DETECTED. IT WAS REPORTED THAT AFTER A MINOR INJURY IN (B)(6) 2023, DURING SPORTS, THE PATIENT FELT CRUNCH AND SHARP PAIN IN THE UPPER THIRD OF THE LOWER LEG. IT WAS REPORTED THAT AN MRI IN (B)(6) 2023 MARKED OSTEOLYSIS AND CYST AROUND THE SCREW SLEEVE. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS ADMITTED WITH PAIN IN THE TIBIAL CANAL. IT WAS REPORTED THAT ON (B)(6) 2023, THE REVISION PROCEDURE WAS DONE AS THE PATIENT HAD CYST IN THE TIBIAL CANAL AREA WHICH INCLUDED THE GRAFT BEING WELL-MAINTAINED, THE REMAINS OF THE SLEEVE AND THE SCREW WERE REMOVED, THE BONE PLASTIC OF THE TIBIOFIBULAR CANAL WAS MADE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Unspecified Tissue Injury

  MAUDE report 17767567 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, A BIO-INTRAFIX TIBIAL SHEATH - SMALL DEVICE WAS USED. ACCORDING TO THE REPORT, THREE MONTHS AFTER SURGERY, THE PATIENT UNDERWENT JOINT CLEARANCE SURGERY IN HOSPITAL DUE TO POOR WOUND HEALING AND CHANGED DRESSING, BUT NO SIGNIFICANT IMPROVEMENT WAS OBSERVED. IT WAS REPORTED THAT THE POSTOPERATIVE CONDITION IMPROVED. IT WAS REPORTED THAT AFTER 11 MONTHS OF SURGERY, THE PATIENT ONCE AGAIN EXPERIENCED POOR WOUND HEALING AND POOR DRESSING CHANGE. THEY WERE HOSPITALIZED AND UNDERWENT JOINT CLEANING SURGERY, AND THEIR CONDITION IMPROVED AND THEY WERE DISCHARGED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 17737226 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022 USING A BIO-INTRAFIX TIBIAL SHEATH - SMALL DEVICE TO FIX THE GRAFT ON THE TIBIAL SIDE. ACCORDING TO THE REPORT, AFTER THE OPERATION, PROPHYLACTIC ANTIBIOTICS WERE USED. IT WAS REPORTED THAT THREE MONTHS AFTER THE OPERATION, THE WOUND ON THE MEDIAL SIDE OF THE TIBIAL TUBERCLE BEGAN TO OOZE REPEATEDLY, AND THE DRESSING CHANGE WAS NOT SIGNIFICANTLY GOOD. THE PATIENT WAS TRANSFERRED TO LOCAL DEBRIDEMENT. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17310800 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - SMALL WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849112 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH SMALL DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15846219 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE LEFT KNEE PERFORMED ON (B)(6) 2022 USING THE BIO-INTRAFIX TIBIAL SHEATH - SMALL DEVICE, THE PATIENT HAD AN INFECTION ON (B)(6) 2022. ACCORDING TO THE REPORT, THE DEVICE WAS THEN REMOVED ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED IN GOOD CONDITION. IT WAS REPORTED THAT NO ADDITIONAL TREATMENT WAS REQUIRED ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15837063 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - SMALL DEVICE WAS CRACKED/BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233585 ↗
• MalfunctionDec 17, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH SM 30MM SUTURE DEVICE BROKE UPON TIGHTENING AND DID NOT FIRE AGAIN AFTER THE FIRST FIRING. 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 13025852 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN CHINA THAT DURING AN UNKNOWN SURGERY, ON (B)(6) 2021, IT WAS OBSERVED THAT THE SHEATH ON THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12152330 ↗
• MalfunctionApr 27, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND MENISCAL REPAIR PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PROTECTIVE SHEATH ON THE BIO-INTRAFIX TIBIAL SHEATH DEVICE WAS BROKEN BEFORE IT WAS KNOCKED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732057 ↗
• MalfunctionDec 14, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE AFFILIATE IN CHINA THAT DURING AN UNKNOWN SURGERY, THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE UPON OPENING THE PACKING, IT WAS NOTED THE END OF THE DEVICE WAS DAMAGED. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A CONSIDERABLE CRACK IN THE CORNER AND THE SHEATH WAS BROKEN INTO MULTIPLE PIECES. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11004561 ↗