MAUDE Adverse Event Report: DEPUY SYNTHES SPINE LEOPARD IMPLANT, 5 DEG LORDOTI; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	186448011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/10/2018
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
L5/s1 tlif dr (b)(6), (b)(6) private hospital (b)(6) 2018.Dr (b)(6) was performing a tlif (transforaminal lumbar interbody fusion) at l5/s1 with the leopard cage, size 11mm.He had prepared the site as per his usual method, the selected cage was packed with bone graft and he started to insert the cage in the usual manner.The cage broke at the end that was attached to the instrument, the end closest to the surgeon, not inside the patient.He removed the instrument and the broken parts of the cage, prepared the site again and then inserted another size 11mm cage.Surgeon was happy that he had removed all parts of the initial cage.There was a minimal delay to the surgery.No ae to patient.Male patient.(b)(6).

• Brand Name: LEOPARD IMPLANT, 5 DEG LORDOTI
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7219549
• Report Number: 1526439-2018-50073
• Device Sequence Number: 101138
• Product Code: MQP
• UDI-Device Identifier: 10705034119083
• UDI-Public: 10705034119083
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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: 186448011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR