MAUDE Adverse Event Report: DEPUY SPINE INC BENGAL IMPLANT LRG 6MM 7 DEG; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187301206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The bengal large 6mm 7 degree cage was not returned to the customer quality unit for evaluation.A review of the device history record (dhr) for the bengal large 6mm 7 degree cage could not be performed as no lot number was provided.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the bengal cage we are unable to confirm the reported issue or identify the root cause.As the device failure cannot be confirmed, this complaint will be closed with no further action.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
Dr.(b)(6) was performing a c4-7 anterior cervical fusion with bengal cage and skyline anterior plate.After dr.(b)(6) completed his discectomy and decompression of the c4-5 disc space, he prepared the endplates and inserted a 5mm large footprint trial, followed by a 6mm large footprint trial.He decided the 6mm large trial was the correct fit for the disc space and asked the surgical technician to prepare a 6mm large bengal implant ((b)(4)).Once loaded on the bengal inserter ((b)(4)), dr.(b)(6) inserted the graft ((b)(4)) in the c4/5 disc space.Dr.(b)(6) used a small mallet to advance the graft into the proper position.After he applied force with the mallet to the inserter approximately 4 times, dr.(b)(6) noticed that deep grooves and surface cracks appeared on the anterior face of the implant.Dr.(b)(6) removed the implant, inspected the disc space and ensured it was free of implant fragments, and proceeded to insert a new cage ((b)(4)).The second cage was inserted into the c4-5 disc space without further incident.Patient consequence? : no.Action taken for procedure:dr.(b)(6) removed the damaged implant.The surgical technician prepared a new implant ((b)(4)), attached the implant to the inserter, and dr.(b)(6) implanted the cage without further incident.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: BENGAL IMPLANT LRG 6MM 7 DEG
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7572894
• Report Number: 1526439-2018-50527
• Device Sequence Number: 2222166
• Product Code: MQP
• UDI-Device Identifier: 10705034137100
• UDI-Public: (01)10705034137100
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K031635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 187301206
• Device Catalogue Number: 187301206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1