NA 498.022Recalls & reported problems
Synthes GmbH · TI 12-POINT NUT-10.5MM · 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 10705034788630), received between Jan 30, 2020 and Jan 30, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
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.
InjuryJan 30, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, A SPINE REVISION SURGERY WAS NEEDED DUE TO A ROD SLIPPAGE AND TWO CAPS AND NUTS LOOSE FROM SMALL STATURE. PRIMARY SURGERY WAS DONE ON (B)(6) 2019. THE SCREWS WERE AT THE LEVEL OF L2 AND L3 ON THE LEFT. THE PATIENT EXPERIENCED BEFORE THE REVISION SURGERY BRUISING AND INFLAMMATION. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). UNKNOWN HOOKS ( PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS 1 OF 6 FOR REPORT (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 9648849 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.