NA 450.135Recalls & reported problems
Synthes GmbH · 4.0MM TI CANC EXPANSIONHEAD SCREW SELF-TAPPING 14MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034780634), received between Jun 25, 2018 and Oct 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Activation, Positioning or Separation Problem1
- Break1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Material Integrity Problem; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT STATUS/OUTCOME WAS POSITIVE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20385516 ↗MalfunctionOct 7, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SCREW BROKE. THE DOCTOR TOLD THE PATIENT IT MIGHT HAVE HAPPENED WHEN HE DID THE SURGERY BACK IN 2020. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20385477 ↗MalfunctionJun 25, 2018Break; Break
IT WAS REPORTED THAT THE TITANIUM (TI) CANCELLOUS EXPANSION HEAD SCREW BROKE DURING AN ANTERIOR CERVICAL DISCECTOMY (ACD) PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, ONE OF THE FINS POPPED OFF AS THE SURGEON WENT TO BRING THE SCREW DOWN FLUSH WITH THE PLATE. THE SECOND FIN ALSO POPPED OFF IN TRYING TO RETRIEVE THE FIRST FIN. WHEN A CONICAL SCREW EXTRACTOR WAS USED, THE TIP OF THE EXTRACTOR BROKE OFF. THE SURGEON THEN USED NON-SYNTHES SURGICAL DRILL AND BURRED THE SCREW DOWN TO BE FLUSH WITH THE PLATE. THE SCREW WAS LEFT BEHIND THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: SPINE PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); SURGICAL DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 4.0MM TI CANC EXPANSION HEAD SCREW SELF-TAPPING 14MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7635492 ↗
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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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