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	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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 on (b)(6) 2019 during the implantation of a 5mm large bengal cervical spacer a flat tamp was turned on the edge and impacted with a mallet shattering the implant.The surgeon was attempting to position the implant flush with the vertebral body.It is unknown if there was a surgical delay.Procedure was successfully completed.Concomitant device: unknown impaction instruments (part: unknown, lot: unknown, quantity: unknown).This report is for one bengal implant lrg 5mm 7 deg.This is report 1 of 1 for (b)(4).

• 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: 9566104
• Report Number: 1526439-2020-00302
• Device Sequence Number: 2866047
• Product Code: MQP
• UDI-Device Identifier: 10705034137094
• UDI-Public: (01)10705034137094
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Report Date (Section B): 12/11/2019

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1