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NA 498.874Recalls & reported problems

Synthes GmbH · 8.0MM TI SIDE-OPENING ILIAC SCREW 100MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034791937), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Unintended Movement1

Patient problems

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

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

  • InjuryFeb 2, 2018Unintended Movement; Unintended Movement

    IT WAS REPORTED THE PATIENT UNDERWENT A UNIVERSAL SPINE SYSTEM (USS) REVISION ON (B)(6) 2018 DUE TO ONE (1) BROKEN ROD AND TWO (2) LOOSE SCREWS. THE PATIENT REPORTED THAT SHE FELT A POP IN HER LOWER BACK IN (B)(6). ON IMAGING, THE SURGEON SAW THAT THE PATIENT HAD BROKEN THE RIGHT ROD JUST BELOW THE S1 SCREW (BROKEN BETWEEN S1 AND ILIAC SCREW). DURING THE REVISION, THE SURGEON REMOVED THE NUTS AND COLLARS FROM THE RIGHT L5 SCREW AND THE RIGHT ILIAC SCREW. HE THEN REPLACED THE RIGHT ILIAC SCREW AND THE RIGHT L5 SCREW. HE SAID THAT THE SCREWS WERE SLIGHTLY LOOSE IN THE BONE. HE REPLACED THEM WITH NEW USS SCREWS THAT WERE 1MM LARGER IN DIAMETER. HE THEN CUT A NEW ROD AND PLACED AN EXPEDIUM UNIVERSAL CONNECTOR ON THE CRANIAL PART OF THE NEW ROD. HE THEN TURNED THE NEW L5 SCREW SO THE SIDE OPENING FACED LATERAL. HE CONNECTED THE NEW ROD TO THE EXISTING RIGHT ROD USING THE EXPEDIUM CONNECTOR BETWEEN THE L2 AND L3 SCREW HEADS. HE THEN CONNECTED THE L5 AND ILIAC SCREWS TO THE NEW ROD. THE OLD RIGHT ROD RAN FROM T4-S1. THE NEW RIGHT ROD RAN ALONG SIDE THE OLD ROD. THE PATIENT WAS INITIALLY IMPLANTED WITH THE USS HARDWARE FROM T4-ILIUM IN (B)(6) OF 2017. NO REPORTED DELAY AND NO PATIENT CONSE

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 7238188 ↗

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