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

Catalog Number	9790052
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Radiological image review: post-op ct for cervical corpectomy.Date of implant and date of recognized hardware failure are unknown.By report one of the screw is backed out.It is not clear on the provided imaging which one backed out.The plate appears long for the bony anatomy and the inferior screw may have violated the bottom end plate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent corpectomy.Post-op, the screws from the plate despite the locking ring backed out of the plate.A revision surgery was performed and a new cage and plate was implanted.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the anterior cervical plate has been damaged.The top surface of the plate has some witness marks near and around the screw insertion points.Optical inspection confirmed the locking rings are still attached to the plate and one of the screw insertion points has some signs of damage on the inner wall which is consistent with not angling the screw enough before tightening.Root cause of failure is undetermined.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: 8361240
• Report Number: 1030489-2019-00183
• Device Sequence Number: 16625158
• Product Code: KWQ
• UDI-Device Identifier: 00721902989070
• UDI-Public: 00721902989070
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K042922
• 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): 06/03/2019

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: 9790052
• Device Lot Number: W07G1159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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