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NA 498.119Recalls & reported problems

Synthes GmbH · 6.0MM TI HARD ROD 500MM · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034788944), received between Oct 4, 2018 and Oct 4, 2018 — classified as 2 injuries.

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

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

  • Break2

Patient problems

  • No Code Available2

Recent adverse event reports

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

  • InjuryOct 4, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO BILATERALLY BROKEN RODS OF SYNTHES UNIVERSAL SPINAL SYSTEM (USS) AT THORACIC 10. THE PATIENT INITIALLY HAD A T2-ILIUM POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE. FOR REVISION SURGERY, THE SURGEON BILATERALLY CUT THE EXISTING RODS ABOVE AND BELOW THE BREAK AT T10, AND CUT TWO NEW 300MM RODS. THE SURGEON THEN CONNECTED THE NEW RODS TO THE EXISTING CRANIAL AND CAUDAL SEGMENTS OF THE RODS ALREADY IMPLANTED ALONG WITH THE EXISTING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 500MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 7933955 ↗
  • InjuryOct 4, 2018Break; Break

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018 DUE TO BILATERALLY BROKEN RODS OF SYNTHES UNIVERSAL SPINAL SYSTEM (USS) AT THORACIC 10. THE PATIENT INITIALLY HAD A T2-ILIUM POSTERIOR SPINAL FUSION ON AN UNKNOWN DATE. FOR REVISION SURGERY, THE SURGEON BILATERALLY CUT THE EXISTING RODS ABOVE AND BELOW THE BREAK AT T10, AND CUT TWO NEW 300MM RODS. THE SURGEON THEN CONNECTED THE NEW RODS TO THE EXISTING CRANIAL AND CAUDAL SEGMENTS OF THE RODS ALREADY IMPLANTED ALONG WITH THE EXISTING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 6.0MM TI HARD ROD 500MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 7933951 ↗

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