MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL LOR 9X11X27, 5 DG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187827411
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
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
During the surgery performed on (b)(4) 2018, it was found that the concorde bullet ((b)(4)) got broken at the site where the insertor was attached and resulted in an unsuccessful insertion.The surgery was successfully completed and there was no adverse consequence to the patient.No further information has been provided by the hospital.
Additional Manufacturer Narrative
(b)(4).Visual examination found that the cage threads were torn.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 cage threads becoming torn cannot be positively determined.However, a possible root cause may likely be that inadvertently cross threading occurred between the cage and cage inserter.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 9X11X27, 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: 7731347
• Report Number: 1526439-2018-50716
• Device Sequence Number: 16521709
• Product Code: MAX
• UDI-Device Identifier: 10705034140087
• UDI-Public: (01)10705034140087
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: 187827411
• Device Catalogue Number: 187827411
• Device Lot Number: ARLDYL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other