Cortical Screw, Locking 37351-18-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09120047295212), received between Jan 9, 2024 and Nov 7, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K063166); they may or may not involve this specific model.

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 4 most recent of 4 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 20629308 ↗
• 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 20629301 ↗
• 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 18474047 ↗
• 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 18474045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063166. One submission often covers many models, so check the product and lot details in each record.

• Z-1600-2026 · Jan 23, 2026 · Open, Classified
  Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 7031
• Z-1718-2019 · May 9, 2019 · Open, Classified
  Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After th