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	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray 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.
Additional Manufacturer Narrative
Product analysis result: visual microscopic functional visual and microscopic examination confirmed the female torx head has been stripped/damaged.The edges of the torx have been deformed.Functional test confirmed the screw was still able to be seated in the zevo plate with no altercations.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: 8509173
• Report Number: 1030489-2019-00417
• Device Sequence Number: 1664175
• Product Code: KWQ
• UDI-Device Identifier: 00643169329409
• UDI-Public: 00643169329409
• 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,Followup
• 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
• Initial Date Received by Manufacturer: 03/16/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement 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