Cortical Screw, Locking 37351-14-NRecalls & reported problems
I.T.S. GmbH · Cortical Screw, Locking, D=3.5mm, L=14mm, SH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09120047295199), received between Jan 9, 2024 and Nov 7, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
Patient problems
- Local Reaction2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 1 MONTH POST-OP THE PATIENT HAD SORT OF ALLERGIC REACTION/IMMUNE RESPONSE. SEVEN MONTHS POST-OP THE PLATE AND SCREWS WERE EXPLANTED AND IMAGES SHOW THAT NON-LOCKING SCREWS OF A DIFFERENT MANUFACTURER WERE USED IN CONJUNCTION WITH I.T.S. IMPLANTS.
Patient problems: Local Reaction
MAUDE report 20629303 ↗InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 1 MONTH POST-OP THE PATIENT HAD SORT OF ALLERGIC REACTION/IMMUNE RESPONSE. SEVEN MONTHS POST-OP THE PLATE AND SCREWS WERE EXPLANTED AND IMAGES SHOW THAT NON-LOCKING SCREWS OF A DIFFERENT MANUFACTURER WERE USED IN CONJUNCTION WITH I.T.S. IMPLANTS.
Patient problems: Local Reaction
MAUDE report 20629302 ↗MalfunctionJan 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT FIVE LOCKING SCREWS GOT LOOSE 3 WEEKS POST-OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18474046 ↗
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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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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