MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X11X23MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 187823111

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot unknown.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 is currently implanted.

Event Description

On (b)(6) 2017, the surgery for degenerative lumbar spondylolisthesis was performed using the concorde system.The fixed area is l4-l5.In (b)(6), the surgeon confirmed under an x-ray that the reported product (part#:1878-23-108 / conc bullet parallel 9x8x23) was backed out.Although the product in question is sitting between the spinal canal, the patient currently has no symptoms.The patient has been under monitoring as it is.No additional information has been provided from the hospital.

• Brand Name: CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X11X23MM
• 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; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6751173
• MDR Text Key: 81302788
• Report Number: 1526439-2017-10616
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10705034139364
• UDI-Public: (01)10705034139364
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 187823111
• Device Catalogue Number: 187823108
• Device Lot Number: ARFCDR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other