MAUDE Adverse Event Report: DEPUY SYNTHES SPINE LEOPARD IMPLANT, PARALLEL, 28X; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 186448109

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

International affiliate reports that at the time of impact, the leopard vertebral body replacement device broke.There is no report of any adverse consequences to the patient at this time.As such, this appears to be a reportable malfunction.If it is learned that there were adverse consequences, the supplemental medwatch report will be filed correcting this event to a serious injury.

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.

Manufacturer Narrative

The 28x parallel leopard implant (product code: 1864-48-109, lot number: anbdog) was returned to the complaints handling unit (chu).Visual inspection of the implant confirms that the side of the cage opposite of the half featuring the threaded insertion hole has broken into several fragments.This is in line with the complaint description which states that the cage broke during impaction.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the cage breaking during impaction cannot be determined from the sample and information provided.A potential root cause may be unexpectedly high forces that may have been placed upon a limited surface area during impaction, leading to the cage fracturing.Ifu-0902-90-077 rev.D states that the broad surface of the insertion tool should be carefully seated fully against the implant during impaction.Impaction forces applied directly to a small surface of the implant could cause fracture of the implant.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LEOPARD IMPLANT, PARALLEL, 28X
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767 CH-
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4310120
• MDR Text Key: 5271481
• Report Number: 1526439-2014-12197
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186448109
• Device Lot Number: ANBDOG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1