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

Model Number	187827408
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.Device not returned for evaluation.
Event or Problem Description
On (b)(6) 2017, tlif surgery was performed using the concorde system in combination with x-tab.The fixed are was l3-l4.On (b)(6) 2017, due to postoperative infections, the surgeon removed the screws at l3-l4 and then made new fixation at l1/l2/l5/s.In addition, as the surgeon tried to remove the cage (part#: 187827408, lot#: apkb5k) from patient, the cage (part#: 187827408, lot#: apkb5k) got broken and then the broken part was left in the patient¿s body.The removal and new fixation operation was completed with a 10-minute delay.No further information has been provided from the hospital.

• 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: 6967863
• Report Number: 1526439-2017-10886
• Device Sequence Number: 16466995
• Product Code: MQP
• UDI-Device Identifier: 10705034140056
• UDI-Public: (01)10705034140056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• 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: 187827408
• Device Catalogue Number: 187827408
• Device Lot Number: APKB5K
• 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