MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH LEOPARD IMPLANT, PARALLEL, 28X; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	186448109
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The leopard 9mm parallel cage implant [product code: 1864-48-109] was not returned to the customer quality unit for evaluation.It was noted that the customer retained the device.A review of the device history record (dhr) for the leopard 9mm parallel cage implant could not be performed as a lot number was not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the leopard cage implant we are unable to confirm the reported issue or identify the root cause.Should more information and/or the device sample become available at a later date, this complaint file will be reopened and the device will then receive a full evaluation.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, upon insertion of leopard cage, surgeon malleted cage and cage broke.All pieces were retrieved.Surgeon replaced with new cage.No delay or adverse consequence to the patient.

• Brand Name: LEOPARD IMPLANT, PARALLEL, 28X
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7601193
• Report Number: 1526439-2018-50550
• Device Sequence Number: 16550218
• Product Code: MQP
• UDI-Device Identifier: 10705034119182
• UDI-Public: (01)10705034119182
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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 Model Number: 186448109
• Device Catalogue Number: 186448109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1