Bioinductive Implant with Arthroscopic Delivery System - Medium 4565Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556735657), received between Apr 8, 2021 and Nov 3, 2025 — classified as 20 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER ROTATOR CUFF ARTHROSCOPY PERFORMED ON (B)(6) 2025, IN WHICH A REGENETEN DEVICE WAS USED, THE PATIENT EXPERIENCED A WORSENED LIMITED RANGE OF MOTION AND PAIN. THE ISSUE WAS TREATED WITH A KENALOG INJECTION. PATIENT CURRENT STATUS IS RECOVERED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23452741 ↗
• MalfunctionOct 31, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF PROCEDURE, WHEN THE BIOINDUCTIVE IMPLANT W/ ARTH DEL MED WAS INTRODUCED INTO THE SHOULDER JOINT, THE METAL ARM THAT HOLDS THE IMPLANT IN PLACE DETACHED FROM THE INSERTER UPON DEPLOYMENT. THE DISLODGED METAL ARM WAS REMOVED IMMEDIATELY WITH GRASPERS. THE SURGEON DECIDED TO REMOVE IT COMPLETELY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442117 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONCE THE BIOINDUCTIVE IMPLANT WAS DEPLOYED, THE DISTAL PORTION OF THE DEPLOYMENT WITH THE METAL BRACKETS WAS COMPLETELY DISCONNECTED FROM THE PROXIMAL SIDE OF THE JUNCTION OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SAME REPORTED DEVICE, ONCE THE DISTAL SECTION CAME OFF THE INSERTER, THE SURGEON WAS ABLE TO SALVAGE THE IMPLANT. THE IMPLANT WAS SEPARATED FROM THE METAL BUTTERFLY DEPLOYMENT WINGS WITH A GRASPER, ALONG WITH THE PLASTIC THAT IT WAS CONNECTED TO, THEN IT WAS SUCCESSFULLY IMPLANTED AFTER REMOVING ALL OTHER OBJECTS. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890036 ↗
• InjuryMar 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY ON (B)(6) 2024, THE INSERTER OF THE REGENETEN BIOINDUCTIVE IMPLANT BROKE OFF. THE SURGEON DID NOT NOTICE THE BREAKAGE IN THE PORTAL DURING THE ORIGINAL SURGERY, THEREFORE THE CASE WAS FINISHED LEAVING THE PIECE INSIDE THE PATIENT. THE PATIENT BEGAN EXPERIENCING POSTOPERATIVE PAIN, AND X-RAYS LATER CONFIRMED THE BROKEN PIECE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE FOREIGN OBJECT. THE PATIENT CONTINUES TO EXPERIENCE PAIN FOLLOWING THE SECONDARY SURGERY.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 21627568 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY EIGHT (8) MONTHS AFTER A RIGHT SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR PERFORMED ON (B)(6) 2022, IN WHICH A REGENETEN BIOINDUCTIVE IMPLANT WAS USED, THE PATIENT EXPERIMENTED PAIN AND DISCOMFORT ON THE RIGHT SHOULDER. AN MRI WITHOUT CONTRAST WAS PERFORMED AND IT REVEALED THE FOLLOWING: MODERATE QUANTITY OF FLUID SUBACROMIAL SUBDELTOID BURSA WITH SYNOVITIS AND POSSIBLE 7 MM CARTILAGINOUS BODY, PARTIAL BURSAL SURFACE TEAR 50% THICKNESS PROXIMAL ANTERIOR INFRASPINATUS TENDON CONTIGUOUS WITH FLUID SIGNAL 1 CM IN LENGTH INTRASUBSTANCE DELAMINATION TEAR AT THE MUSCULOTENDINOUS JUNCTION, DISTAL SUPRASPINATUS TENDINOSIS, AND SUBCORACOID BURSITIS WITH FLUID AND DEBRIS SUPERFICIAL TO THE SUBSCAPULARIS TENDON INFERIOR TO THE CORACOID. CONSEQUENTLY, THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPIC REVISION ROTATOR CUFF REPAIR BY HEALING RESPONSE, SUBACROMIAL DECOMPRESSION WITH REMOVAL OF MULTIPLE LOOSE BODIES FROM PRIOR SURGICAL REPAIR AND PRP INJECTION ON (B)(6) 2023. DURING THE PROCEDURE, THE SURGEON ENCOUNTERED FIFTY (50) LOOSE RICE BODIES FROM THE DEGRADATION OF THE PREVIOUSLY IMPLANTED REGENETEN PATCH, WHICH WERE REMOVED. LESS THAN THREE (3) MONTHS

  Patient problems: Bursitis; Foreign Body Reaction; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Synovitis

  MAUDE report 20803372 ↗
• MalfunctionNov 11, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE BOINDUCTIVE IMPLANT WAS IMPLANTED IN THE TOP OF THE ROTATOR CUFF REPAIR. AFTER IMPLANTATION, BUT BEFORE BEING FIXED TO THE TENDON, THE TOP PLASTIC PART BROKE OFF WITHIN FIVE MINUTES. ADDITIONALLY, THE METAL PRONGS HOLDING THE IMPLANT DETACHED, AND THE IMPLANT ITSELF SEPARATED. THESE PARTS WERE FLOATING IN THE JOINT AND ENTANGLED IN SOFT TISSUE, REQUIRING AN HOUR TO REMOVE FROM THE PATIENT. TWO ARTHROSCOPIC GRASPERS WERE USED FOR THE REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT THE BOINDUCTIVE IMPLANT AND WITH A SURGICAL DELAY OF 1 HOUR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652950 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE UPPER JAW ON THE REGENETEN DELIVERY SYSTEM BROKE AFTER DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017276 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY ONE YEAR AFTER A PARTIAL THICKNESS-REGENETEN ONLY REPAIR PROCEDURE USING A BIOINDUCTIVE IMPLANT, A PATIENT HAD TO UNDERGO A REVISION LARGE FULL THICKNESS PROCEDURE. THE DOCTOR WAS CONCERNED THE REGENETEN IMPLANT CAUSED A BIOLOGIC REACTION THAT CAUSED THE FULL THICKNESS TEAR. PATIENT WAS NOT INJURED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Insufficient Information; Muscle/Tendon Damage; Unspecified Tissue Injury

  MAUDE report 19122281 ↗
• InjuryDec 5, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A PROCEDURE DONE IN (B)(6) OF 2023, THE PATIENT CAME BACK IN NOVEMBER FOR A REVISION SURGERY, BECAUSE WAS HAVING PAIN AND STIFFNESS. A REVISION SURGERY WAS PERFORMED AND A SMALL PORTION OF THE REGENECTIN IMPLANT WAS FLOATING FREELY WITHIN THE SHOULDER. THE IMPLANT DID IT'S JOB WELL, AND THE CUFF WAS FULLY HEALED BESIDES THE SMALL PORTION THAT WAS FLOATING AND DID NOT INTEGRATE. THE PORTION WAS REMOVED AND THERE WAS NO NEED TO PLACE ANOTHER IMPLANT. NO FURTHER SURGERY IS ANTICIPATED.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 18267456 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT ACHILLES TENDON ENDOSCOPIC DEBRIDEMENT, EXCISION OF HAGLUND¿S LESION AND REGENETEN OPERATION WHERE A BIOINDUCTIVE IMPLANT WAS USED, THE PATIENT HAD SERIOUS DISCHARGE OVER THE WOUND, EVEN AFTER THE WOUNDS WERE HEALED AND STO WAS DONE. A CULTURE WAS TAKING FROM THE WOUND AND IT WAS NEGATIVE FOR ANY HARMFUL PATHOGEN. WHEN THE DISCHARGE WAS NOTICED, THE PATIENT WAS PROVIDED WITH ORAL AUGMENTIN, BUT THE PATIENT COULD NOT TOLERATE IT AND THIS LET TO VOMITING. THEREFORE, THE PATIENT WAS ADMINISTER 3 DAYS OF IV AND 5 DAYS OF ORAL TREATMENT. AFTER 3 WEEKS THE WOUND HAD DRIED UP, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18092723 ↗
• InjurySep 14, 2023Unstable; Unstable

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY, USING A REGENETEN IMPLANT, THE PATIENT'S TISSUE HEALED. HOWEVER, NOT ALL PARTS OF THE IMPLANT STAYED INTACT. ON (B)(6) 2023, A REVISION ROTATOR CUFF REPAIR SURGERY WAS PERFORMED TO REMOVE THE LOOSE BODY REGENETEN IMPLANT FROM THE PATIENT'S SHOULDER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17750023 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY PROCEDURE WITH A REGENETEN DEVICE, THE PATIENT EXPERIENCED AN ONGOING SHOULDER PAIN. A THREE MONTH SCAN SHOWED LARGE CUFF TEAR/ATROPHY AND DEGENERATION. THE PATIENT UNDERWENT AN ASPIRATION TO CHECK FOR INFECTION; THE FLUID WAS CLEAR AND NOT TURBID, NOT SUSPICIOUS FOR INFECTION. PATIENT HAD A SUPRASCAPULAR NERVE BLOCK IN CLINIC TO HELP WITH PAIN AND IT WAS REFERRED TO PAIN MANAGEMENT TEAM FOR SERIES OF SUPRASCAPULAR NERVE BLOCKS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Tissue Breakdown

  MAUDE report 16547425 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE LITERATURE REVIEW "SUBACROMIAL-SUBDELTOID BURSITIS WITH RICE BODIES AFTER ROTATOR CUFF REPAIR WITH A COLLAGEN SCAFFOLD IMPLANT"; 1 PATIENT HAD SUBACROMIAL-SUBDELTOID BURSITIS WITH RICE BODIES AFTER A ROTATOR CUFF REPAIR PROCEDURE USING A REGENETEN BIOINDUCTIVE IMPLANT. THE EVENT WAS RESOLVED BY ARTHROSCOPIC SUBACROMIAL DEBRIDEMENT. THE PATIENT OUTCOME IS RECOVERED WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 16436026 ↗
• InjuryOct 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SIX MONTHS POST SURGERY, A RADIOLOGISTS IDENTIFIED A FOREIGN BODY IN A MRI AROUND THE SHOULDER BLADE; WHICH SEEMS TO BE A BIOINDUCTIVE IMPLANT, THAT COULD HAVE MIGRATED. THE EVENT HAPPENED AFTER PROCEDURE WHICH WAS COMPLETED WITH THE REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 15663457 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE ARTHROSCOPIC IMPLANTATION OF A REGENETEN BIOINDUCTIVE IMPLANT ON (B)(6) 2022; THE PATIENT EXPERIENCED A FOREIGN BODY REACTION LEADING TO IMPLANT ENCAPSULATION, THUS IT DID NOT INTEGRATE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 15135890 ↗
• InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPY PROCEDURE WITH A BIOINDUCTIVE IMPLANT ON (B)(6), A PATIENT WENT IN FOR REVISION DEBRIDEMENT SURGERY ON (B)(6) DUE TO SUBACROMIAL SPACE TURNING TO BONE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911643 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER TWO YEARS OF A ROTATOR CUFF REPAIR USING 'TENDON ANCHORS, BONE ANCHORS AND THE BIOINDUCTIVE IMPLANT', A REVISION SURGERY WAS PERFORMED TO GRAB IMPLANT BECAUSE IT DIDN'T WORK PROPERLY IN THE BONE. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361359 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE BIOINDUCTIVE IMPLANT WAS USED ON A SHOULDER ROTATOR CUFF REPAIR. AFTER PROCEDURE IT WAS NOTICED THAT THE PATIENT GOT AN INFECTION. A REVISION SURGERY WAS REQUIRED FOR WASH OUT THE INFECTION. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13060735 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THREE MONTHS OF AN ACHILLES REATTACHMENT PROCEDURE WITH FOUR SUTURE ANCHORS; FROM ANOTHER UNKNOWN VENDOR; AND RENEGETEN BIOINDUCTIVE IMPLANT WITH TENDON AND BONE ANCHORS, THE PATIENT WAS STILL SWOLLEN AND WITH SOME PAIN. A SECOND SURGERY WAS PERFORMED AFTER 5 MONTHS OF THE PROCEDURE AND THERE WAS NO VISIBLE INFECTION. THE REGENETEN IMPLANT WAS REMOVED, TISSUE WAS EVALUATED AND DEEMED NO FURTHER REPAIR WAS NECESSARY. THE PATIENT IS DOING WELL.

  Patient problems: Inflammation; Pain

  MAUDE report 12907466 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A PATIENT WERE PREVIOUSLY TENDON ANCHORS WERE USED. A GRANULOMA CYST AND A LARGE BONE VOID WERE IDENTIFIED AT THE PROCEDURE. CULTURES WERE TAKEN. CURRENT STATUS OF THE PATIENT AND HOW THE ISSUE WAS RESOLVED IS UNKNOWN.

  Patient problems: Granuloma; Rupture

  MAUDE report 12531224 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER PROCEDURE, WHERE REGENETEN BIOINDUCTIVE IMPLANT WAS USED, THE PATIENT HAD PAIN AND IRRITATION ON (B)(6) 2021. ON A SECOND SURGERY, IT WAS NOTICED THAT THE DEVICE BECOME DISLODGED AND WAS NOT SECURED TO THE SUPRASPINATUS TENDON. IT HAD BUNCHED UP AND WAS PARTIALLY ATTACHED TO THE ACROMION. THE IMPLANT, BONE ANCHORS AND TENDON ANCHORS WERE REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 12445090 ↗
• InjuryJun 16, 2021Expulsion; Expulsion

  IT WAS REPORTED THAT 8 MONTHS AFTER A PROCEDURE WHERE AN REGENETEN WAS IMPLANTED, THE PATIENT CAME WITH SHOULDER PAIN. AN MRI SHOWED THAT THE IMPLANT CAME DISLODGED AND SHIFTED LATERALLY AND ADDITIONALLY IT LOOKED AS IF IT NEVER RESORBED. SURGEON IS PLANNING TO POTENTIALLY REMOVE THE IMPLANT. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12007727 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SURGERY WITH A REGENETEN IMPLANT, DOCTOR DETERMINED THAT PATIENT WAS HAVING COMPLICATIONS. A REVISION SURGERY WAS SCHEDULED IN ORDER TO TREAT THE EVENT. IT IS UNKNOWN WHEN THE REVISION SURGERY WILL BE PERFORMED AND THE STATUS OF THE PATIENT IS AS WELL UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11828391 ↗
• InjuryApr 8, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE BIOINDUCTIVE IMPLANT W/ARTH DEL MED TORE INSIDE PATIENT. PRODUCT WAS UNUSUALLY SOFT AS SOON AS IT ENTERED THE SHOULDER. GRAFT WAS NOT SOAKED IN SALINE BEFORE ENTERING THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP WITH A DELAY OF 30 MINUTES OR LESS. PATIENT STATUS IS FINE AND IS IN REGULAR POST-OP PROTOCOL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633648 ↗