MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTE-STACK® SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	9192507
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(6) 2017, patient presented with pre-op diagnosis as lumbar degeneration.For which, patient underwent posterior lumber interbody fusion (plif) at levels l2-5.Intra-op, during the implantation of cage, the surgeon had to impact the cage to get it into the disc space, during which the cage broke.Another cage was used for insertion which too broke during impaction.The product came in contact with the patient.No fragment of the implant remained in the patient.No patient symptoms or complications were reported as a result of this event.

• Brand Name: VERTE-STACK® SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 6841129
• Report Number: 1030489-2017-01995
• Device Sequence Number: 10953014
• Product Code: MQP
• UDI-Device Identifier: 00885074520544
• UDI-Public: 00885074520544
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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 Expiration Date: 08/02/2018
• Device Catalogue Number: 9192507
• Device Lot Number: H10F0728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR