Erisma®-LP 18911039Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700780625154), received between Aug 30, 2018 and Mar 6, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2020Material Fragmentation; Material Fragmentation

  SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF COMPLETELY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVER TOP OF IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799565 ↗
• MalfunctionMar 4, 2020Material Fragmentation; Material Fragmentation

  THE SURGEON EXPERIENCED TWO BROKEN TIPS ON THE PEDICLE SCREW DRIVERS. ONE OF THE TIPS WAS BROKEN OFF IN THE SCREW AND DISPOSED OF WITH THE SCREW. THE TIP WAS RETRIEVED AND NOT LEFT IN THE PATIENT. THE SECOND DRIVER TIP WAS CRACKED, BUT NOT BROKEN OFF COMPLETELY. THE BROKEN DRIVER OCCURRED AT L5-S1 AND BOTH BREAKAGES WERE AT THE SAME PILOT HOLE. NO HARM OCCURRED TO THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786165 ↗
• InjuryNov 7, 2019Material Fragmentation

  SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF CLEANLY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVERTOP OF IT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9291175 ↗
• MalfunctionAug 30, 2018Material Fragmentation; Material Fragmentation

  THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW HEAD INSIDE OF THE PATIENT WITHOUT ANY POSSIBILITY OF MIGRATION. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832296 ↗
• MalfunctionAug 30, 2018Material Fragmentation; Material Fragmentation

  THE DISTAL TIP OF SCREWDRIVER BROKE OFF WHILE INSERTING A POLYAXIAL PEDICLE SCREW. THE BROKEN TIP HAS NOT BEEN RETRIEVED. IT IS CAPTURED IN THE SCREW HEAD INSIDE OF THE PATIENT WITHOUT ANY POSSIBILITY OF MIGRATION. SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832086 ↗

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