MAUDE Adverse Event Report: DEPUY SPINE INC CONCORDE INSERTER-BAYONET; DRIVER, PROSTHESIS

Model Number	287901009
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Spinal Cord Injury (2432); No Code Available (3191)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Patient identifier: (b)(6).(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 the surgeon was attempting to insert a 9x7x23mm concorde cage into a collapsed disc space at the l1-l2 level.During impaction, the implant come off the inserter and the inserter concussed the cord.At that point, the surgeon defaulted on the interbody.The case was completed without issues.The patient has shown no signs of deficit or injury.The surgeon would like to why the inserter disengaged from the cage.It was also reported that a dural patch was applied.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Visual inspection of the returned device did not find any immediately observable damage to the instrument.The threads at the tip of the inserter were in good condition and the shaft could be easily manipulated in the handle.The threads of the inserter could still mesh with the remaining threads of the cage, allowing the cage to be retained by the inserter.There were no issues found in the use of this instrument.It functions as intended and does not feature any damage.A review of the device history records is not necessary as no product failure has been identified.No root cause analysis is necessary at this time as no product failures have been identified during the course of this investigation.As there has been no issue identified with the device, 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 INSERTER-BAYONET
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8599313
• Report Number: 1526439-2019-51629
• Device Sequence Number: 2011163
• Product Code: HWR
• UDI-Device Identifier: 10705034219899
• UDI-Public: (01)10705034219899
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 287901009
• Device Catalogue Number: 287901009
• Device Lot Number: NM1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention