MAUDE Adverse Event Report: GENESYS SPINE BINARY ANTERIOR CERVICAL PLATING SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION APPLIANCE

Model Number	GCP2-232
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While the genesys spine binary anterior cervical plate has a locking mechanism that accommodates a high degree of screw angulation, the degree of screw angulation does still have its limits.If the screw angulation exceeds the limits of the cervical plate design the surgeon could experience difficulty engaging the lock.Based on the information provided and the inspection of the returned cervical plate the root cause of the incident is believed to be screw angulation that exceeded the degree of angulation that the lock can reliably accommodate.
Event or Problem Description
During a two-level acdf procedure, the locking mechanism on a cervical plate did not engage one cervical screw.As a result, the plate was removed and replaced with a cervical plate of the same size.There was no patient effect and the total procedure delay was less than 5 minutes.

• Brand Name: BINARY ANTERIOR CERVICAL PLATING SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION APPLIANCE
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of tx hwy south; bld three, suite 600; austin TX 78746
• MDR Report Key: 6595987
• Report Number: 3008455034-2017-00003
• Device Sequence Number: 788828
• Product Code: KWQ
• UDI-Device Identifier: M719GCP22320
• UDI-Public: +M719GCP22320/$$7WT20161013EC
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: GCP2-232
• Device Lot Number: WT20161013E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 68