NA 201.879Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982143143), received between Dec 7, 2018 and Dec 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 7, 2018Break; Migration; Break; Migration

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF LOOSE LEFT ELBOW RADIAL HEAD PROSTHESIS IMPLANT AND LOOSE RADIAL PLATE AND SCREWS AND CERCLAGE WIRE. PREVIOUS INCISION WAS OPENED AND WAS EXTENDED DISTALLY. THE SUPINATOR MUSCLE WAS OPENED OVER THE POSTERIOR OSSEOUS NERVE WHICH HAD SEVER SCAR AROUND IT NEEDING AN EXTENSIVE NEUROLYSIS THAT WAS LENGTHY AND TOOK 3 TO 4 TIMES LONGER THAN USUAL. THE POSTERIOR INTEROSSEOUS NERVE WAS SCARRED AND STRETCHED DISTALLY NEAR THE PLATE; WAS SEVERELY SCARRED TO THE PLATE AND RADIUS BONE. WHILE PROTECTING THE NERVE, THE NERVE WAS COMPLETELY LIFTED OFF THE PLATE. PERIOSTEUM WAS OPENED TO EXPOSE THE HARDWARE. THERE WAS REDDISH FLUID AROUND THE IMPLANTS. 2 DIFFERENT IMPLANTS WERE REMOVED, ONE WAS RADIAL HEAD, THE OTHER WAS PLATES AND SCREWS AND CERCLAGE WIRE. THE RADIUS BONE WAS SHUCKED AND THE WRIST WAS COMPRESSED AND THE PROXIMAL RADIUS HAD NO PROXIMAL MIGRATION. FLUOROSCOPIC IMAGES OF ELBOW CONFIRM ALL HARDWARE WERE REMOVED. REMAINING BONE INTACT AND ULNOHUMERAL JOINT LOCATED. ON (B)(6) 2016, THE PATIENT FELL OVER A STEP AND HIT LEFT ARM ON CONCRETE WHILE SHE WAS EXERCISING TRYING TO DO A HURDLE DURING AGILITY DRILLS. THE PATIEN

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 8141679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen