MAUDE Adverse Event Report: DEPUY SYNTHES SPINE UNKNOWN CAGE/SPACER

Catalog Number UNK CAGE/SPACER

Device Problem Collapse (1099)

Patient Problem Spinal Column Injury (2081)

Event Date 01/01/2006

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

This report is being filed after the subsequent review of the following literature article: cage failure following replacement of the third lumbar vertebral body in hodgkin¿s disease zeh, a., bernstein, a., genest, m., held, a., & hein, w.(2006).Cage failure following replacement of the third lumbar vertebral body in hodgkin's disease.Zeitschrift fur orthopadie und ihre grenzgebiete, 144(3), 328-331.N=1 case of failure and collapse of the device.

• Brand Name: UNKNOWN CAGE/SPACER
• Type of Device: UNKNOWN
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SARL; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7234257
• MDR Text Key: 98781670
• Report Number: 1526439-2018-50098
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/19/2018

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: UNK CAGE/SPACER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR