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

Catalog Number	8792813
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Scarring (2061)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray review: post op xray for c3-5 acdf shows back out of c3 screw.There is an o/c on c1-2 fusion construct present posteriorly and the c2-3 level is slipped.Motion at this level and failure of fusion, failure to hook the plate or oversizing the plate may have contributed to screw back out.By report, this screw was unable to be removed.Product was not 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 patient was pre-operatively diagnosed with backed out screw of left c3 and underwent anterior cervical discecectomy and fusion.Post-op, screw had loosened at c3.This was observed in the follow up on (b)(6) 2017.The patient did not state any discomfort, but did mention a fall from a standing position two weeks prior to his follow up visit.On (b)(6) 2018, an attempt was done to remove the screw/hardware but aborted due to scarring.

• Brand Name: ZEPHIR ANTERIOR CERVICAL 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: 7272532
• Report Number: 1030489-2018-00226
• Device Sequence Number: 1028801
• Product Code: KWQ
• UDI-Device Identifier: 00721902610653
• UDI-Public: 00721902610653
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K030327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8792813
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 62