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

Catalog Number	G3002041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Spinal Cord Injury (2432)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Spinal cord injury and rupture of posterior wall of patient's vertebral body.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.Note: the following products were used in the surgery.Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose.Part#g7783513; 510k#k141632; udid# (b)(4), part# g7783513; 510k# k141632; udid#(b)(4), part#g7783515; 510k#k141632; udid#(b)(4), part#g7783515; 510k#k141632; udid#(b)(4), part#g7783515; 510k#k141632; udid#(b)(4), part#g7783515; 510k#k141632; udid#(b)(4), part#3032028; 510k#exempt part#7080906; 510k#exempt part#3030007; 510k#exempt part#3032012; 510k#exempt part#3030007; 510k#exempt.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 due to cervical spondylotic myelopathy.Intra-operatively ,there was a possibility of spinal cord injury beyond the posterior wall of the vertebral body and rupture of posterior wall of patient's vertebral body.

• Brand Name: ZEVO 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: 9224098
• Report Number: 1030489-2019-01193
• Device Sequence Number: 1611414
• Product Code: KWQ
• UDI-Device Identifier: 00643169327641
• UDI-Public: 00643169327641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2026
• Device Catalogue Number: G3002041
• Device Lot Number: 0620902W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/23/2019
• 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
• Patient Age: 51 YR
• Patient Weight: 78