MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	7714015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with cervical stenosis and underwent 2 level anterior cervical discectomy and fusion (acdf) surgery at c5-7 levels.During surgery, the screw snapped into 2 pieces.The product came in contact with the patient.No fragment of the screw remained in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirms screw breakage approximately one and a half thread down from the base of the bone screw head.Microscopic examination of the head and threaded shaft of the screw did not identify a pre-existing surface defect near the area of damage.Dimensional examination of the major and minor diameters of the bone screw confirm relevant bone screw dimensions are within print specification.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEVO¿ ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 8058807
• Report Number: 1030489-2018-01466
• Device Sequence Number: 16863898
• Product Code: KWQ
• UDI-Device Identifier: 00643169329423
• UDI-Public: 00643169329423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: Health Professional
• Device Catalogue Number: 7714015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR