MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEPHIR ANTERIOR CERVICAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	8792715
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
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
Procedure: anterior cervical discectomy and fusion it was reported that the patient presented with cervical disc herniation.Intra-op, the screw was slipped.The product came in contact with the patient.No patient symptoms or complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the head of the screw is stripped from what appears to be overload while driving the screw in.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEPHIR ANTERIOR CERVICAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7559017
• Report Number: 1030489-2018-00785
• Device Sequence Number: 1432749
• Product Code: KWP
• UDI-Device Identifier: 00681490540940
• UDI-Public: 00681490540940
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K994239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 8792715
• Device Lot Number: H5349001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR