MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VENTURE ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	9790065
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
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 underwent anterior cervical discectomy and fusion (acdf) at c4-7 due to cervical degenerative disc disease.Post-op, loosening of hardware occur due to non union.Apparent esophageal tear occur due to prominent hardware at implantation site.The patient underwent revision surgery for the removal of the implant.
Additional Manufacturer Narrative
Product analysis result: visual microscopic the plate was returned with one of the integrated locking mechanisms missing.The remaining locking feature show deformation were it appears the screws were at one time in place then pushed back through the screw locking feature.The screw hole at the level of the missing lock was measured and meets print spec.It appears that at some point the screws were under the locks.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTURE ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7468042
• Report Number: 1030489-2018-00612
• Device Sequence Number: 18875235
• Product Code: KWQ
• UDI-Device Identifier: 00721902989124
• UDI-Public: 00721902989124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042922
• 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,Followup
• Report Date (Section B): 10/04/2018

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: 9790065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 08/08/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/04/2018
• 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; Required Intervention
• Patient Age: 69 YR