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

Catalog Number	9193009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
Event or Problem Description
It was reported that patient with spinal stenosis underwent spine decompression and discectomy surgery at l4-s1.Intra-op, when spacer was loaded on the inserter and was hammered to place spacer inside the disc space, it broke.The product was replaced with new implant to successfully complete the surgery.No fragments of the implant remained inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis: visual review confirms multiple fractures.Microscopic examination of the implant displays multiple fracture rays emanating away from the area of fracture origin, the superior inserter interface hole diameter.This is consistent with brittle overload of the implant due to significant impaction force during attempted implant insertion into the vertebral space.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6577591
• Report Number: 1030489-2017-01253
• Device Sequence Number: 16370122
• Product Code: MQP
• UDI-Device Identifier: 00885074520681
• UDI-Public: 00885074520681
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K052261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2017

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: 12/13/2024
• Device Catalogue Number: 9193009
• Device Lot Number: H5325827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 08/01/2017; 08/01/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 08/02/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1