MAUDE Adverse Event Report: DEPUY SYNTHES SPINE CONCORDE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187827512
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Surgeon was inserting the concorde bullet cage in between vertebra body with mallet knocked on the top notch of cage inserter several times until it flushed.However, when surgeon detached the inserter from the cage and he founds out the cage was broke into half inside patient body.The cage was unable to take out as it was difficult.

• Brand Name: CONCORDE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6967869
• Report Number: 1526439-2017-10887
• Device Sequence Number: 1299310
• Product Code: MQP
• UDI-Device Identifier: 10705034140193
• UDI-Public: (01)10705034140193
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K041722
• 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
• Report Date (Section B): 10/03/2017

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: Physician
• Device Model Number: 187827512
• Device Catalogue Number: 187827512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/22/2017
• Patient Sequence Number: 1