TRUESPAN ORTHOCORD 228162Recalls & reported problems
Medos International Sàrl · TRUESPAN Meniscal Repair System PLGA 24 DEGREES ORTHOCORD Violet braided composite suture Size 2-0, (2) PLGA Backstops, and (1) Applier with 24 DEGREES needle Depth Stop: 10mm-20mm Plus or Minus 1mm; Needle: 10mm Plus or Minus .13mm · Class 2 · Implant
All models of TRUESPAN ORTHOCORD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos TRUESPAN meniscal repair system is a kit used to repair torn knee cartilage with sutures. Many of its 451 reports describe parts that do not fit with other components, parts that break, and difficulty advancing or deploying implants. The reports list 4 injuries, no deaths and 447 malfunctions, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 460
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 460 adverse event reports that list this exact device (DI 10886705026050), received between Dec 9, 2019 and Sep 21, 2026 — classified as 4 injuries, 456 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (242 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility242
- Break118
- Difficult to Advance34
- Detachment of Device or Device Component33
- Migration27
- Premature Activation24
- Material Deformation20
- Physical Resistance/Sticking15
Patient problems
- No Clinical Signs, Symptoms or Conditions438
- No Consequences Or Impact To Patient20
- Foreign Body In Patient5
- Not Applicable2
- Swelling/ Edema2
- Abscess1
- Hematoma1
- Inflammation1
Recent adverse event reports
The 25 most recent of 460 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846835 ↗MalfunctionSep 21, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839550 ↗MalfunctionSep 21, 2026Use of Device Problem; Device-Device Incompatibility
It was reported that during an unspecified surgical procedure, when the deploying the first anchor of the TRUESPAN 24 DEGREE PLGA anchor device, it was observed that the click of the release was heard, but no anchor or sutures were seen in the joint space. It was reported that the anchor did not fire, and the device did not work as intended. It was reported that a new anchor device was used and the device worked as intended. It was not reported if there was a delay in the procedure due to the event. It was reported that there was no harm to the patient or user. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50837646 ↗MalfunctionSep 16, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794680 ↗MalfunctionSep 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722998 ↗MalfunctionSep 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722996 ↗MalfunctionSep 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722328 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717942 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Noise, Audible
It was reported that during an anterior cruciate ligament/meniscus surgery, the surgeon stated the deployment of the TRUESPAN ORTHOCORD implants felt "different" than the normal. It did not click like normal with deployment - the device either made a faint noise to question if the implant deployed or made a loud clunk. The implants deployed even with the unusual sounds; however, the suture loops appeared to be wound together which made tensioning more difficult than normal. The surgeon expressed that he was not sure if he was able to fully tension the implants, or if the suture was bunched together, causing laxity in the repair. There was no patient or user harm reported. There was no significant delay in surgery. All available information has been disclosed.Report 2 of 3 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717935 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717928 ↗MalfunctionSep 4, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50615763 ↗MalfunctionAug 28, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50498970 ↗MalfunctionAug 25, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438843 ↗MalfunctionAug 20, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355760 ↗MalfunctionAug 14, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252677 ↗MalfunctionAug 14, 2026Break; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50252674 ↗MalfunctionAug 6, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50153828 ↗MalfunctionJun 25, 2026Premature Activation
IT WAS REPORTED THAT DURING THE MENISCAL REPAIR SURGERY, AFTER 1ST FIRING WITH TRUESPAN 24 DEGREE PLGA, TWO PLATES WERE DEPLOYED AT THE SAME TIME. 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 25620377 ↗MalfunctionJun 24, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING MEDIAL MENISCUS REPAIR SURGERY, TWO TRUESPAN ORTHOCORD IMPLANTS DID NOT FULLY DEPLOY. THE IMPLANTS WERE CUT AWAY AND REMOVED BY THE SURGEON AND A NEW IMPLANT INSERTED. THERE WAS A DELAY HOWEVER NO HARM TO PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610721 ↗MalfunctionJun 23, 2026Device Damaged Prior to Receipt by User
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE TRUESPAN ORTHOCORD DEVICE WOULD NOT RELEASE. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DAMAGED OUT OF THE BOX. IT WAS NOT ABLE TO DEPLOY THE IMPLANTS. 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 25598819 ↗MalfunctionJun 11, 2026Crack; Use of Device Problem
IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRUESPAN 24 DEGREE PLGA DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEPLOYER WITH THE WHITE SLEEVE CRACKED AT THE DISTAL END. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474143 ↗MalfunctionJun 10, 2026Premature Activation
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE TRUESPAN 24 DEGREE PLGA DEVICE AFTER 1ST FIRING (DEPLOYMENT), TWO PLATES WERE DEPLOYED AT THE SAME TIME. CHANGED 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 ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459902 ↗MalfunctionJun 10, 2026Premature Activation
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR PROCEDURE THE TRUESPAN 24 DEGREE PLGA DEVICE AFTER 1ST FIRING (DEPLOYMENT), TWO PLATES WERE DEPLOYED AT THE SAME TIME. CHANGED 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 ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459894 ↗MalfunctionJun 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TRUESPAN ORTHOCORD DEVICE NOT DEPLOYED CORRECTLY. IT WAS PULLED OUT OF THE MENISCUS AS THE DEVICE WAS PULLED BACK TO SET THE SECOND ANCHOR. IT HAPPENED WITH 3 TRUESPAN PLGA 24. 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 25459853 ↗MalfunctionJun 10, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE TRUESPAN ORTHOCORD DEVICE NOT DEPLOYED CORRECTLY. IT WAS PULLED OUT OF THE MENISCUS AS THE DEVICE WAS PULLED BACK TO SET THE SECOND ANCHOR. IT HAPPENED WITH 3 TRUESPAN PLGA 24. 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 25459824 ↗
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TWINFIX 72202595Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE446 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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