NA 04.600.018Recalls & reported problems
Synthes GmbH · 6.0MM TI PRECONTOURED ROD 80MM STRAIGHT LENGTH/400MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705034734132), received between Apr 13, 2018 and Apr 13, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
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.
InjuryApr 13, 2018Break; Break
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A PATIENT ON (B)(6) 2018. THE PATIENT HAD A PREVIOUS POSTERIOR T10-ILIUM SURGERY IN 2014 WITH SYNTHES USS (UNIVERSAL SPINE SYSTEM) HARDWARE. AT AN UNKNOWN POINT IN TIME, THE PATIENT'S RIGHT ROD BROKE BETWEEN THE S1 AND ILIAC SCREWS. THE LEFT ROD WAS NOT BROKEN. DURING THE REVISION, THE SURGEON REMOVED THE NUTS AND COLLARS FROM THE L4 AND ILIAC SCREWS BILATERALLY. HE THEN CUT THE RODS JUST CAUDAL TO THE L5 SCREWS. THE SURGEON ALSO REMOVED THE LEFT AND RIGHT S1 SCREWS. THERE WAS NO ALLEGATION OF DEFICIENCY OR MALFUNCTION AGAINST THE NUTS AND COLLARS (4 EACH), OR THE S1 SCREWS (2 EACH). REPORTED CONCOMITANT DEVICES: USS NUTS (PART # 498.003, LOT # UNKNOWN, QTY. 4); USS COLLARS (PART # 498.010, LOT # UNKNOWN, QTY. 4); AND USS SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QTY. 2). THIS REPORT ADDRESSES REVISION SURGERY DUE TO POSTOPERATIVE ROD BREAKAGE. THE INTRAOPERATIVE MALFUNCTIONS WHICH OCCURRED DURING THE REVISION SURGERY HAS BEEN CAPTURED UNDER LINKED COMPLAINT (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 7428536 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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