MAUDE Adverse Event Report: DEPUY SPINE INC BENGAL IMPLANT LRG 5MM 7 DEG; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187301205
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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 the surgeon was impacting the cage and the device broke into four pieces.The device was being impacted with a nylon mallet.The amount of force being used was very little.Surgical delay of 5 minutes was reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination found that the cage had fractured in four segments.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 bengal 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: BENGAL IMPLANT LRG 5MM 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: 8085995
• Report Number: 1526439-2018-51079
• Device Sequence Number: 13526955
• Product Code: MQP
• UDI-Device Identifier: 10705034137094
• UDI-Public: (01)10705034137094
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 187301205
• Device Catalogue Number: 187301205
• Device Lot Number: 192551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/04/2018
• Patient Sequence Number: 1