Binary 1 (REF GCP237)Recalls & reported problems
Genesys Orthopedics Systems LLC · Binary A-O Screw Driver · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M719GCP2370), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2017Break; Fracture; Break; Fracture
DURING AN ACDF PROCEDURE THE PHYSICIAN HAD INSERTED AND SECURED AN ANTERIOR CERVICAL PLATE. THE PHYSICIAN WANTED TO REMOVE ONE CERVICAL SCREW AND REPLACE IT WITH A DIFFERENT LENGTH SCREW. DURING SCREW REMOVAL THE TIP OF THE REMOVAL DRIVER BROKE OFF (SEPARATED). THE PHYSICIAN USED A NERVE HOOK [INSTRUMENT] TO RETRIEVE THE BROKEN TIP OF THE REMOVAL DRIVER. THE SALES REP STATED THERE WERE NO ABNORMALITIES DURING INSERTION OR REMOVAL OF THE SCREW PRIOR TO THE INSTRUMENT FAILURE. THE SURGEON REPORTED THAT THE TIP OF THE INSTRUMENT WAS RETRIEVED AND DISCARDED. THERE WAS NO EFFECT ON THE PATIENT, PHYSICIAN, OR HOSPITAL STAFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7042407 ↗
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- Elegance® Anterior Cervical Plate 53430114Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430240Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430236Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
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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