MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL LOR 9X8X27, 5 DG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187827408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/21/2018
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
On (b)(6) 2018, the tlif surgery for spinal canal stenosis was performed by using the concorde bullet.The fixed area was l5-s1 during the surgery, the following event was confirmed by the surgeon.After attaching the cage (187827408, lot#: 159462) to an inserter (part#: unknown), the surgeon tried to insert the cage by impacting the inserter with a hammer (part#: unknown).While adjusting the insertion angle of the cage, the inserter come off the cage.Then, it was found that the cage was broken, thus he was unable to hold it with the inserter.He extracted the broken cage by using a plier and then inserted another new cage.No broken pieces were found left in the patient¿s body, and the surgery was successfully completed with a less-than-30-minute delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found the cage had fractured in half.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause cannot be positively determined.However, it should be noted that polymer/carbon-fiber cages are designed to support physiologic loads.Higher than anticipated torque levels when applied to insertion tools, can cause splitting or fracture of cages.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONCORDE BUL LOR 9X8X27, 5 DG
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7600867
• Report Number: 1526439-2018-50551
• Device Sequence Number: 1694984
• Product Code: MAX
• UDI-Device Identifier: 10705034140056
• UDI-Public: (01)10705034140056
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: Health Professional
• Device Model Number: 187827408
• Device Catalogue Number: 187827408
• Device Lot Number: 159462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1