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

Catalog Number 188902028

Device Problem Collapse (1099)

Patient Problems Spinal Column Injury (2081); Not Applicable (3189)

Event Date 12/06/2017

Event Type  Injury  

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 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
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7157653
• MDR Text Key: 96160329
• Report Number: 1526439-2018-50002
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034159928
• UDI-Public: 10705034159928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 188902028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR