MAUDE Adverse Event Report: DEPUY SYNTHES SPINE COUGAR; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	187105108
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.
Event or Problem Description
Anterior scoliosis.173205110 alif cage small 5degree 10mm this item broke as it was positioned in the patient and then removed.All pieces of the implant were obtained and discarded by the surgical team.A different sized cage was then implanted at this level of the spine and there was no delay in surgery.187105108 alif cage small 5degree 8mm the thread of this item was stripped during implantation when the insertion instrument was used to manoeuvre the implant into position.The surgeon no longer needed to position the implant any further after this manoeuvre and therefore the implant stayed insitu and there was no added delay in surgery.

• Brand Name: COUGAR
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6904203
• Report Number: 1526439-2017-10774
• Device Sequence Number: 1354174
• Product Code: MQP
• UDI-Device Identifier: 10705034135342
• UDI-Public: (01)10705034135342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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: Physician
• Device Model Number: 187105108
• Device Catalogue Number: 187105108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1