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Erisma®-LP 18710024Recalls & reported problems

Clariance · Screwdriver · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700780623303), received between Aug 24, 2016 and Aug 31, 2016 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K153326); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Issue1
  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2016Device Issue; Device Issue

    THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW IN THE LUMBAR REGION OF THE SPINE. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW INSIDE OF THE PATIENT. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 5917907 ↗
  • MalfunctionAug 24, 2016Material Fragmentation; Material Fragmentation

    THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW IN THE LUMBAR REGION OF THE SPINE. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW INSIDE OF THE PATIENT. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 5899583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153326. One submission often covers many models, so check the product and lot details in each record.

  • Z-1986-2019 · Jul 1, 2019 · Terminated
    Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Eri

Other Orthosis, Spondylolisthesis Spinal Fixation devices

All Orthosis, Spondylolisthesis Spinal Fixation devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.