CoRoent 1903013Recalls & reported problems
Nuvasive, Inc. · Interlock II Screw, 4.0x13mm Self-Tap · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887517945716), received between Aug 1, 2023 and Oct 3, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2023Fracture; Fracture
ON (B)(6) 2023 A SPINAL PROCEDURE WAS PERFORMED AT C4/6. ON (B)(6) 2023 IT WAS DISCOVERED THE SCREW AT C5 WAS BROKEN. NO PATIENT INJURIES REPORTED AND NO REVISION SURGERY IS SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861386 ↗MalfunctionAug 1, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL CERVICAL INTERBODY FUSION PROCEDURE AT C5 TO C7 USING TWO (2) INTERBODY IMPLANTS WITH INTERFIXATION. SUBSEQUENTLY, IT WAS IDENTIFIED THAT THE SUPERIOR INTERFIXATION SCREW FOR THE C6/C7 INTERBODY FRACTURED APPROXIMATELY EIGHT (8) MONTHS LATER. NO REVISION PROCEDURE HAS BEEN SCHEDULED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17438611 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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