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

Catalog Number	8799142
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
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) due to spinal stenosis.Intra-op, the locking plate broke off while physician tried to turn the locking plate.The plate was fitted and bent to fit the patient anatomy and it was screwed into the vertebra before turning on and breaking.No patient symptoms or complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the cervical plate was returned with one of the antimigration caps missing.Optical inspection of the area where the cap is missing did not reveal any damages that could contribute to the cap breaking off.It appears the antimigration cap was overloaded causing the cap to come loose and break from the plate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ZEPHIR ANTERIOR CERVICAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8559854
• Report Number: 1030489-2019-00485
• Device Sequence Number: 1836857
• Product Code: KWQ
• UDI-Device Identifier: 00681490540797
• UDI-Public: 00681490540797
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K994239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8799142
• Device Lot Number: 0375910W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1