MAUDE Adverse Event Report: DEPUY SYNTHES SPINE X-MESH ALT LG 0 DEG 28-38MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	188902028
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Spinal Column Injury (2081); Not Applicable (3189)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Cage collapsed post-op when we looked at film next day.Patient consequence? :yes.Patient consequence description:longer anesthesia, longer surgery.Action taken for procedure:compressed posterior elements and re-aligned patient cage.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: X-MESH ALT LG 0 DEG 28-38MM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7157653
• Report Number: 1526439-2018-50002
• Device Sequence Number: 1017628
• Product Code: MQP
• UDI-Device Identifier: 10705034159928
• UDI-Public: 10705034159928
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: 188902028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR