MAUDE Adverse Event Report: DEPUY SPINE INC COUGAR LS 18X16X55 15-DEG LORD; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	189155616
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	02/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
Cfrp cougar lateral cage item (b)(4) sheered/split upon implanting into disc space.The surgeon explained to me after the case that the cage appeared to have been cross threaded, he noticed this as he was attempting to disengage the cage from the inserter it was providing resistance.He said the cage split at its most fragile spot, the inner threads of the cage where the inserter engages the implant.He said that there appeared to be a crack alongside the ti markings but his opinion was that it did not sheer through the ti and therefor he felt it still was stable in his clinical opinion, and removing it could have done more damage than just leaving it and providing extra fixation with a cervical plate 22mm and four large diameter 4.0x18mm screws along with four perc viper cortical fix screws posterior and two rods.Patient consequence? :unknown.Patient consequence description:no immediate consequence, surgeon left implant inside interbody and secured the space using a lateral plate for extra support as well as posterior fixation.Action taken for procedure:the surgeon had to place a lateral plate with 4 screws for additional stabilization.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

• Brand Name: COUGAR LS 18X16X55 15-DEG LORD
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7297198
• Report Number: 1526439-2018-50172
• Device Sequence Number: 19141630
• Product Code: MQP
• UDI-Device Identifier: 10705034356976
• UDI-Public: 10705034356976
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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 Catalogue Number: 189155616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1