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

Model Number	187823111
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6751173
• Report Number: 1526439-2017-10616
• Device Sequence Number: 11028688
• Product Code: MQP
• UDI-Device Identifier: 10705034139364
• UDI-Public: (01)10705034139364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 187823111
• Device Catalogue Number: 187823108
• Device Lot Number: ARFCDR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other