MAUDE Adverse Event Report: DEPUY SPINE INC BENGAL STACKABLE CAGE SYSTEM CAGE BOTTOM, LARGE 14 X 16 X 9MM, 4 DEGREES; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 177304409

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: plr.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, after assembling bengal stackable cage and filling with graft the surgeon was impacting the cage into position when the bottom segment snapped into pieces and broke away.The cage was removed.There was a surgical delay of fifteen (15) minutes.Fragments were removed.The procedure was completed successfully.There were no patient consequences.This report involves one (1) bengal stackable cage system cage bottom, large 14 x 16 x 9mm, 4 degrees.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: BENGAL STACKABLE CAGE SYSTEM CAGE BOTTOM, LARGE 14 X 16 X 9MM, 4 DEGREES
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12172380
• MDR Text Key: 261736162
• Report Number: 1526439-2021-01407
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034060729
• UDI-Public: 10705034060729
• Combination Product (y/n): N
• PMA/PMN Number: K190284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 177304409
• Device Catalogue Number: 177304409
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 08/18/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN IMPACTION INSTRUMENTS