CoRoent 6790153Recalls & reported problems
Nuvasive, Inc. · CoRoent SI Handle, Counter Torque · Class 1
All models of CoRoent (64)
Data updated Oct 16, 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 00887517360854), received between Apr 22, 2021 and Apr 22, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Migration1
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.
MalfunctionApr 22, 2021Migration; Migration
ON A (B)(6) 2021 A REVISION PROCEDURE OCCURRED TO EXTEND THE EXISTING CONSTRUCT TO L2 UTILIZING ROD CONNECTORS. THE PATIENT HEARD A NOISE COMING FROM THEIR BACK ON A UNKNOWN DATE AND IT WAS DISCOVERED IN A SUBSEQUENT FOLLOW UP AT THAT THE RIGHT SIDE ROD HAS DISASSOCIATED. A REVISION OCCURRED ON (B)(6) 2021 TO ADJUST THE SLIPPED ROD. THE SURGICAL WOUND WAS CLOSED, THAT DAY SUBSEQUENTLY IT WAS DISCOVERED THE LEFT SIDE ROD HAD SLIPPED AS WELL. IT WAS REPORTED THAT THE CROSS CONNECTOR WAS AT FAULT FOR THE SLIPPAGE. NO REVISION HAS OCCURRED OR WAS PLANNED AT THE TIME OF REPORTING FOR THE SECOND SLIPPED ROD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712350 ↗MalfunctionApr 22, 2021Fracture; Fracture
A PATIENT UNDERWENT A CORPECTOMY PROCEDURE WHERE THE L2 VERTEBRAL BODY WAS BEING REPLACED. DURING THE PROCEDURE THE VERTEBRAL IMPLANT WAS TWO LARGE FOR THE SPACE AND WAS FORCIBLY HAMMERED INTO PLACE. ON (B)(6) 2021 A HOSPITAL NURSE CONTACTED THE INVOLVED REP TO INFORM THEN A PORTION OF THE COUNTER TORQUE INSTRUMENT WAS MISSING FROM THE DEVICE AND POST OPERATIVE IMAGES CONFIRMED THAT MISSING PORTION WAS LEFT IN PATIENT. ON (B)(6) 2021 A REVISION PROCEDURE OCCURRED AND THE RETRIEVED FRAGMENT WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11711968 ↗
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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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