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

Catalog Number	187827408
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
It was reported that during a spinal surgery on (b)(6) 2018, the concorde bullet spinal system lordotic implant 9 x 8 x 27mm, 5 degrees, broke after striking it to insert it.The fixed area was unknown.The surgery was completed with a twenty-minute (20) delay.There was no adverse consequence to the patient.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the cage had fractured near the threaded hole.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 for the concorde cage fracturing 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: 7314225
• Report Number: 1526439-2018-50203
• Device Sequence Number: 11131846
• Product Code: MAX
• UDI-Device Identifier: 10705034140056
• UDI-Public: 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,Followup
• Report Date (Section B): 02/13/2018

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 Catalogue Number: 187827408
• Device Lot Number: APDBLP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018; 04/13/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/10/2018; 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1