OMEGA 3362-5-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327092875), received between Aug 21, 2015 and Jul 8, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K955306); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2019Difficult to Insert; Loose or Intermittent Connection

  A REGISTRAR WAS COMPLETING A DHS. WHEN INSERTING THE LAG SCREW IT APPEARED TO BECOME LOOSE FROM THE INSERTER. THEY THEN TRIED TO PUT THE PLATE OVER THE LAG SCREW AND IT WOULD NOT GO OVER THE LAG SCREW. A CONSULTANT WAS CALLED AND THEY CAME TO THEATRE TO HELP. THEY THEN REMOVED THE 100MM LAG SCREW AND REPLACED IT WITH A 105MM LAG SCREW. THEY COMPLETED THE CASE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT ADDED AROUND 1 HOURS OPERATING TIME TO THE PROCEDURE. THE DHS LAG SCREW WAS INSERTED USING THE 1 STEP INSERTION TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767097 ↗
• MalfunctionNov 19, 2018Break

  THE HOSPITAL REPORTED THE FOLLOWING EVENT: "THE OPERATING THEATER OF OUR HOSPITAL DECLARED A MATERIOVIGILANCE INCIDENT WHEN USING CERVICAL OMEGA II SCREWS 100 MM ST, REF 33625100, LOT Y02502 AND L09620. DESCRIPTION OF THE FACTS: THE 2 OMEGA 100 MM DHS SCREWS BROKE AT THE THREADED PITCH DURING INSTALLATION. THE MATERIOVIGILANCE NUMBER TO BE RECALLED FOR ALL CORRESPONDENCE IS (B)(4)." LONGER INTERVENTION. ACTIONS TAKEN TO COMPLETE THE INTERVENTION: SCREW CHANGE (OF THE SCREW DIAMETER).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084077 ↗
• MalfunctionNov 19, 2018Break

  THE HOSPITAL REPORTED THE FOLLOWING EVENT: "THE OPERATING THEATER OF OUR HOSPITAL DECLARED A MATERIOVIGILANCE INCIDENT WHEN USING CERVICAL OMEGA II SCREWS 100 MM ST, REF 33625100, LOT Y02502 AND L09620. DESCRIPTION OF THE FACTS: THE 2 OMEGA 100 MM DHS SCREWS BROKE AT THE THREADED PITCH DURING INSTALLATION. THE MATERIOVIGILANCE NUMBER TO BE RECALLED FOR ALL CORRESPONDENCE IS (B)(4)." LONGER INTERVENTION. ACTIONS TAKEN TO COMPLETE THE INTERVENTION: SCREW CHANGE (OF THE SCREW DIAMETER).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8084076 ↗
• MalfunctionAug 21, 2015Metal Shedding Debris; Failure to Advance; Mechanical Jam; Naturally Worn

  IT WAS REPORTED VIA STRYKER SALES REP, THAT DURING A DHS SURGERY ON A (B)(6) PATIENT, THE THREADS ON THE LAG SCREW WERE WORN OUT AND THE LAG SCREW WOULDN'T GO ANY FURTHER. THE LAG SCREW BECAME STUCK IN THE INSERTER. THE SURGEON REMOVED THE SCREW AND NOTICED THAT IT WAS WORN AND METAL DEBRIS WAS SEEN INSIDE THE PATIENT. THE LAG SCREW WAS EXTRACTED BY PUTTING THE KEYED PLATE AT THE TOP OF THE BARREL AND BY TURNING IT TO LOOSEN. IT WAS FURTHER REPORTED THAT THE SURGERY WAS FINISHED BY INSERTING ANOTHER LAG SCREW AFTER 45 MIN-1 HOUR DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5021734 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955306. One submission often covers many models, so check the product and lot details in each record.

• Z-1865-2008 · Jan 25, 2005 · Terminated
  Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plate