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SURFIX CC045NDRecalls & reported problems

Newdeal · SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 mm to 65 mm. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780051152), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1
  • Loss of Range of Motion1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 6, 2022Fracture; Fracture

    IT WAS REPORTED THAT THREE (3) MONTHS AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE HEADS OF ONE (1) CORTICAL SCREW LOCK SCREW (D4.5-L45) INSERTED DISTAL TO THE OSTEOTOMY BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SCREW: THE INTRAOSSEOUS PART OF THE SCREW WAS NOT REMOVED TO PREVENT FLOOR DAMAGE. DRILLING FOR THE NEW SCREW WAS DONE BICORTICALLY IN A SOMEWHAT MORE HORIZONTAL ALIGNMENT. THE PLATE WAS RETAINED.

    Patient problems: Failure of Implant; Loss of Range of Motion; Pain

    MAUDE report 15923890 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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