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

Catalog Number	7713515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis results: visual microscopic visual and microscopic inspection confirmed the screw has broke about 2 threads down from the head of the screw.Microscopic inspection of the fracture surface revealed a fairly flat surface with circular material flow and some material deformation where the screw broke at the thread.It appears the screw broke due to torsional overload.X-ray review result: intra-op films from revision surgery c4-6 acdf show fracture of plate and screws at c4-5.It is unclear if an interbody graft is present at c4-5 or what the fusion status at c5-6 is.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Type of procedure or technique used: anterior cervical discectomy and fusion (acdf) levels implanted: c4-6 it was reported that post-op, the implanted screw broke which resulted in non union.Fragments including distal end of screw that broke off remained inside the patient.Patient suffered neck/arm pain and the patient underwent revision surgery for the removal of implant.

• 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: 8568204
• Report Number: 1030489-2019-00502
• Device Sequence Number: 1537864
• Product Code: KWQ
• UDI-Device Identifier: 00643169329270
• UDI-Public: 00643169329270
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 7713515
• Device Lot Number: H5225548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/01/2019
• 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; Required Intervention