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ApeX 121-50320Recalls & reported problems

Extremity Medical, LLC · Large PIP Post - 4.6 x 20mm (30 deg) · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842078108987), received between Oct 24, 2023 and Oct 24, 2023 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture1
  • Material Fragmentation1

Patient problems

  • Bone Fracture(s)1
  • Failure of Implant1

Recent adverse event reports

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

  • MalfunctionOct 24, 2023Fracture; Material Fragmentation; Fracture; Material Fragmentation

    THE JOINT WAS EXPOSED AND USED X- RAY TO DETERMINE THE SIZE. IT WAS FELT THAT THE PATIENT HAD PLENTY OF BONE SPACE FOR THE LARGE X-POST AT 20MM IN LENGTH. THE GUIDE WIRE WAS PLACED AND THEN RE POSITIONED TO GET IT CENTERED DOWN THE CANAL. THE REAMER WAS USED AND THE SURGEON SAID HE SUNK THE BLACK LINE 2-3MM BELOW THE BONE SURFACE. IT WAS SUGGESTED THAT IF THIS WAS HARD BONE THEN HE SHOULD DRILL, BUT THE DR. FELT IT WAS NOT NECESSARY. THE X-POST WAS IMPLANTED AND BECAME STUCK 3/4 OF THE WAY IN AND WOULD NOT MOVE. DR. PROVIDED MORE FORCE WHICH SNAPPED THE END OF THE SCREW DRIVER OFF AND LEFT IN THE POST. DR. HAD TO FISH THE HEAD OF THE SCREWDRIVER OUT. ONCE THIS WAS MANAGED, HE TRIED TO TAKE OUT THE POST WITH THE OTHER SCREWDRIVER. HOWEVER, DUE TO THE FORCE REQUIRED TO REMOVE THE POST, THE CANNULATED SCREWDRIVER SNAPPED AGAIN. HE TRIED TO LOCATE ANOTHER 2MM HEX SCREWDRIVER, HOWEVER THERE WAS NO SPARE AVAILABLE. HE TRIED TO USE THE EXPOSED POST WINDOW TO LEVER THE POST OUT, BUT THIS UNFORTUNATELY SNAPPED THE HEAD OF THE POST OFF. DR. WAS THEN FORCED TO PARTIALLY SPLIT THE BONE IN ORDER TO RELEASE THE REST OF THE X POST.

    Patient problems: Bone Fracture(s); Failure of Implant

    MAUDE report 17995358 ↗

Other Screw, Fixation, Bone devices

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Sources and updates

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