TRUESPAN ORTHOCORD 228160Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886705026036), received between Nov 8, 2019 and Mar 18, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE TRUESPAN 0 DEGREE PLGA ANCHOR DEVICE COULD NOT BE DEPLOYED. IT WAS REPORTED THAT THE DEVICE WAS CHANGED. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 24627183 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT 2X TRUESPAN 0 DEGREE PLGA DEVICE ANCHORS DID NOT COME OUT FROM THE TIP DESPITE SEVERAL ATTEMPTS AND FORCING ON THE TRIGGER. 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 23690890 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, IT WAS OBSERVED THAT 2X TRUESPAN 0 DEGREE PLGA DEVICE ANCHORS DID NOT COME OUT FROM THE TIP DESPITE SEVERAL ATTEMPTS AND FORCING ON THE TRIGGER. 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 23690886 ↗
• MalfunctionAug 6, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PLGA DEVICE WAS UNABLE TO BE INSTALLED. INABILITY TO PLACE THE IMPLANT. 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 22724260 ↗
• MalfunctionMay 7, 2025Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRUESPAN 0 DEGREE PLGA DEVICE WAS ALREADY OUTSIDE OF THE NEEDLE WHEN TAKING IT FROM THE PACKAGE. DURING AN IN HOUSE ENGINEERING EVALUATION IT WAS FOUND THAT THE DEVICE FELL APART. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980142 ↗
• MalfunctionMay 7, 2025Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRUESPAN 0 DEGREE PLGA DEVICE WAS ALREADY OUTSIDE OF THE NEEDLE WHEN TAKING IT FROM THE PACKAGE. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS FOUND THAT THE DEVICE FELL APART. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979876 ↗
• MalfunctionMar 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FIRST TRUESPAN 0 DEGREE PLGA DEVICE WAS DETACHED FROM THE NEEDLE BEFORE INSERTING BEFORE USING THE NEEDLE INSIDE THE JOINT. THEN A SECOND TRUESPAN 0 DEGREE PLGA DEVICE FAILED AFTER PUNCTURING THE FIRST TIME THROUGH THE MENISCUS WITHOUT DEPLOYING THE FIRST IMPLANT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE 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 21558817 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FIRST TRUESPAN 0 DEGREE PLGA DEVICE WAS DETACHED FROM THE NEEDLE BEFORE INSERTING BEFORE USING THE NEEDLE INSIDE THE JOINT. THEN A SECOND TRUESPAN 0 DEGREE PLGA DEVICE FAILED AFTER PUNCTURING THE FIRST TIME THROUGH THE MENISCUS WITHOUT DEPLOYING THE FIRST IMPLANT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE 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 21558816 ↗
• MalfunctionMay 1, 2024Premature Activation; Premature Activation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT WHILE USING THE TRUESPAN 0 DEGREE PGLA DEVICE, TWO IMPLANTS WERE ALREADY OUT AFTER THE FIRST IMPLANT SHUT THROUGH THE MENISCUS AND HAD TO BE RETRIEVED. IT WAS REPORTED THAT IT DID NOT PULL OUT TOO FAR AFTER THE FIRST IMPLANT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 19220876 ↗
• MalfunctionApr 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE TRUESPAN 0 DEGREE PLGA DEVICE HAD A KNOT WAS TWISTED WHILE INSERTING THE ANCHOR. THIS BLOCKED THE TRIGGERING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125311 ↗
• MalfunctionMar 15, 2024Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE RED TRIGGER OF THE TRUESPAN 0 DEGREE PLGA DEVICE BROKE WHILE DEPLOYING THE FIRST IMPLANT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912686 ↗
• MalfunctionMay 23, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE SALES REP IN SPAIN THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICE WAS BROKEN UPON OPENING ITS BLISTER. ACCORDING TO THE REPORT, THE CARDBOARD BOX WAS IN PERFECT CONDITION. 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 16988625 ↗
• MalfunctionMay 22, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING AN UNKNOWN PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE HANDLE ON THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICE WAS BLOCKED; AND THEREFORE COULD NOT BE USED. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16977181 ↗
• MalfunctionJan 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY SALES REP THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICE WOULD NOT FIRE. 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 16179954 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6)2022 , IT WAS OBSERVED THAT THE IMPLANT ON THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICE HAD ALREADY COME OUT OF THE DEVICE. 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 15716627 ↗
• MalfunctionSep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE FIRST IMPLANT WAS ALREADY OUT OF THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICE. THERE WAS AN UNSPECIFIED SLIGHT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458928 ↗
• MalfunctionJun 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICES DID NOT FUNCTION PROPERLY AS THEY DID NOT FIRE THE IMPLANTS. 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 14878680 ↗
• MalfunctionJun 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT TWO TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE DEVICES DID NOT FUNCTION PROPERLY AS THEY DID NOT FIRE THE IMPLANTS. 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 14878495 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A TRUESPAN 0 DEGREE PLGA ANCHOR DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228219 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A TRUESPAN 0 DEGREE PLGA ANCHOR DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228211 ↗
• MalfunctionFeb 19, 2021Break; Migration; Break; Migration

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE TRUESPAN 0 DEGREE PLGA DEVICE BROKE AND THE IMPLANTS WERE COMING OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT A DELAY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349151 ↗
• MalfunctionFeb 19, 2021Break; Migration; Break; Migration

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE TRUESPAN 0 DEGREE PLGA DEVICE BROKE AND THE IMPLANTS WERE COMING OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT A DELAY REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11349149 ↗
• MalfunctionFeb 16, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PLGA DEVICE DID NOT REACH PAST THE CAPSULE AND HAD TO BE CUT OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A SEVEN MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333870 ↗
• MalfunctionFeb 16, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TRUESPAN 0 DEGREE PLGA DEVICE BROKE WHEN SLIDING GUN INTO THE KNEE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A SEVEN MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333852 ↗
• MalfunctionJan 6, 2020Failure to Discharge; Failure to Discharge

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE ARTHROSCOPY THE TRUESPAN MENISCAL REPAIR SYSTEM PLGA 0 DEGREE MISFIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THIS DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553226 ↗