INTRAFIXRecalls & reported problems across all models
Medos International Sàrl · 32 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 222
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 32 models of INTRAFIX by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 222 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2018 and Sep 30, 2026 — classified as 13 injuries, 209 malfunctions.
The most frequently reported specific device problem is “Break” (146 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 INTRAFIX problems
Device problems
- Break146
- Migration or Expulsion of Device12
- Device Contamination with Chemical or Other Material11
- Device Markings/Labelling Problem10
- Material Deformation10
- Adverse Event Without Identified Device or Use Problem7
- Crack7
- Device Contaminated During Manufacture or Shipping7
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- No Consequences Or Impact To Patient64
- Not Applicable6
- No Known Impact Or Consequence To Patient4
- Unspecified Tissue Injury4
- Unspecified Infection3
- Muscular Rigidity2
- No Code Available2
INTRAFIX models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTRAFIX 254807Fastener, fixation, biodegradable, soft tissue52 reports
- INTRAFIX 254808Fastener, fixation, biodegradable, soft tissue28 reports
- INTRAFIX 254806Fastener, fixation, biodegradable, soft tissue18 reports
- INTRAFIX 254836ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- INTRAFIX 254683Screw, fixation, bone10 reports
- INTRAFIX 254801Fastener, fixation, biodegradable, soft tissue10 reports
- INTRAFIX 254809Fastener, fixation, biodegradable, soft tissue10 reports
- INTRAFIX 254802Fastener, fixation, biodegradable, soft tissue9 reports
- INTRAFIX 254826Fastener, fixation, nondegradable, soft tissue9 reports
- INTRAFIX 254681Screw, fixation, bone6 reports
- INTRAFIX 254803Fastener, fixation, biodegradable, soft tissue6 reports
- INTRAFIX 254834ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- INTRAFIX 254682Screw, fixation, bone4 reports
- INTRAFIX 254684Screw, fixation, bone4 reports
- INTRAFIX 254800Fastener, fixation, biodegradable, soft tissue4 reports
- INTRAFIX 254822Fastener, fixation, nondegradable, soft tissue4 reports
- INTRAFIX 254680Screw, fixation, bone3 reports
- INTRAFIX 254829ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- INTRAFIX 254833ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- INTRAFIX 254815Fastener, fixation, nondegradable, soft tissue3 reports
- INTRAFIX 254825Fastener, fixation, nondegradable, soft tissue3 reports
- INTRAFIX 254685FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- INTRAFIX 254832ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INTRAFIX 254828ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INTRAFIX 254835ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- INTRAFIX 254816Fastener, fixation, nondegradable, soft tissue2 reports
- INTRAFIX 254818Fastener, fixation, nondegradable, soft tissue2 reports
- INTRAFIX 254831ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INTRAFIX 254830ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- INTRAFIX 254814Fastener, fixation, nondegradable, soft tissue1 report
- INTRAFIX 254821Fastener, fixation, nondegradable, soft tissue1 report
- INTRAFIX 254819Fastener, fixation, nondegradable, soft tissue1 report
Recent INTRAFIX 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
It was reported that during tan unspecified surgery, the INTRAFIX sheath was broken off. Another device was used to complete the surgery. There were no adverse consequences to the patient and no surgical delay. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943640 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931966 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873664 ↗MalfunctionSep 23, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873662 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829138 ↗MalfunctionSep 10, 2026Break
It was reported that during an unspecified surgical procedure, it was discovered that when the screw on the INTRAFX ADVBR SCW10X30W/LGSHTH device was inserted, it broke off. All the broken pieces were removed from the patient. 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 50716581 ↗MalfunctionSep 10, 2026Break
It was reported that during a Knee arthrometer collateral ligament repair surgical procedure when inserting the INTRAFX ADVBR (b)(6)W/LGSHTH screw device, it was observed that the screw was broken off. It was reported that all pieces were removed from the patient. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713047 ↗MalfunctionSep 9, 2026Break
It was reported that during the surgery, when insert the INTRAFIX screw device, 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 could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698181 ↗MalfunctionSep 9, 2026Break
It was reported that during Cruciate ligament reconstruction surgery, the sheath on the INTRAFIX was broken off, all the pieces were removed from the patient. Changed another one to continue the surgery, 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.Report 1 of 2 for (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695623 ↗MalfunctionSep 9, 2026Break
It was reported that during Cruciate ligament reconstruction surgery, the sheath on the INTRAFIX was broken off, all the pieces were removed from the patient. Changed another one to continue the surgery, 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.Report 2 of 2 for PC-(b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695611 ↗MalfunctionSep 9, 2026Break
It was reported that during the surgery, when inserting the INTRAFIX screw, the screw was broken. All the pieces were removed from the patient. Another device was used to complete the surgery. There were no reports of surgical delay. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693434 ↗MalfunctionSep 2, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572862 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549114 ↗MalfunctionAug 27, 2026Break
It was reported that during an Arthroscopic Ligament Repair procedure, it was discovered that the INTRAFX ADVBR SCW9X23 W/LGSHTH device broke off during implantation. All the broken parts were removed from the patient. 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 50475245 ↗MalfunctionAug 27, 2026Break
It was reported that during an Anterior Cruciate Ligament Reconstruction procedure, it was discovered that the sheath on the INTRAFX ADVBR SCW9X23 W/LGSHTH device 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 50474503 ↗
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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