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

Model Number 186448109

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

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 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
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7601193
• MDR Text Key: 112148792
• Report Number: 1526439-2018-50550
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034119182
• UDI-Public: (01)10705034119182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 186448109
• Device Catalogue Number: 186448109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1