MILAGRORecalls & reported problems across all models
Medos International Sàrl · 26 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 695
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 0
We found 26 models of MILAGRO by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 695 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2017 and Sep 30, 2026 — classified as 55 injuries, 640 malfunctions.
The most frequently reported specific device problem is “Break” (518 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MILAGRO problems
Device problems
- Break518
- Adverse Event Without Identified Device or Use Problem43
- Fracture29
- Crack26
- Difficult to Advance24
- Material Deformation19
- Material Twisted/Bent10
- Migration8
Patient problems
- No Clinical Signs, Symptoms or Conditions395
- No Consequences Or Impact To Patient204
- Not Applicable40
- Unspecified Tissue Injury26
- No Known Impact Or Consequence To Patient11
- No Code Available10
- Foreign Body In Patient6
- Unspecified Infection6
MILAGRO models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MILAGRO 231816FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE127 reports
- MILAGRO 231807Screw, fixation, bone98 reports
- MILAGRO 231817FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE96 reports
- MILAGRO 231803FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE84 reports
- MILAGRO 231814FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE58 reports
- MILAGRO 231818FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE38 reports
- MILAGRO 231821FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE29 reports
- MILAGRO 231822FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE27 reports
- MILAGRO 231813FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE23 reports
- MILAGRO 219500ORTHOPEDIC MANUAL SURGICAL INSTRUMENT18 reports
- MILAGRO 231831Screw, fixation, bone18 reports
- MILAGRO 231823Screw, fixation, bone16 reports
- MILAGRO 231804FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE13 reports
- MILAGRO 231819FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE13 reports
- MILAGRO 231809Screw, fixation, bone9 reports
- MILAGRO 219496ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- MILAGRO 231811FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE5 reports
- MILAGRO 231824Screw, fixation, bone3 reports
- MILAGRO 231826FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE3 reports
- MILAGRO 231812FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- MILAGRO 219497ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- MILAGRO 231867FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- MILAGRO 231868FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- MILAGRO 231828FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- MILAGRO 231832Screw, fixation, bone1 report
- MILAGRO 231869FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
Recent MILAGRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951659 ↗MalfunctionSep 29, 2026Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938195 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794096 ↗MalfunctionSep 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763053 ↗MalfunctionSep 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612110 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460660 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457382 ↗MalfunctionAug 19, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50322669 ↗MalfunctionJul 28, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052077 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051642 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE MILAGRO ADVANCE SCREW 7X30MM DEVICE BROKE DURING SCREW IMPLANTATION. ALL PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS DELAYED BY TEN MINUTES. A DIFFERENT DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25670047 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, WHEN THE MILAGRO SCREW WAS INSERTED, IT WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665107 ↗MalfunctionJun 24, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, WHEN THE MILAGRO SCREW WAS INSERTED, THE SCREW WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25605589 ↗MalfunctionJun 23, 2026Device Damaged Prior to Receipt by User; Material Deformation
DURING SURGERY DOCTOR USED SCREW DURING THE ACL REPAIR PROCEDURE. UPON OPENING AND INSPECTION OF THE IMPLANT, IT WAS OBSERVED THAT THE THREAD OF THE SCREW APPEARED PARTIALLY BROKEN/DAMAGED. HENCE, THE SCREW COULD NOT BE USED FOR THE PROCEDURE. ANOTHER SCREW WAS SUBSEQUENTLY USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE CONCERNED IMPLANT IS AVAILABLE FOR INSPECTION. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). ## ***.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599386 ↗MalfunctionJun 18, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT THE MILAGRO INSCR SMALL-SIZE 6X23 DEVICE WAS FOUND TO BE UNSTERILIZED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 25547299 ↗
Other Medos International Sàrl products
- TRUESPAN ORTHOCORD6 models · 4,109 reports
- FMS39 models · 3,588 reports
- EXPEDIUM291 models · 3,312 reports
- EXPEDIUM VERSE90 models · 2,686 reports
- EXPRESSEW6 models · 2,459 reports
- OMNISPAN ORTHOCORD3 models · 1,581 reports
- HEALIX ADVANCE ORTHOCORD21 models · 1,311 reports
- PROWLER SELECT9 models · 1,066 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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