MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG N/A; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	9192510
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographic image review : intra-op images of l4-5 tlif ap and lateral picture of x-rays monitors shows an interbody shaft which has been detached from the inserter and appears to be placed on the spinal canal.No final image provided to demonstrate re-positioning.The review was conducted by a hcp.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with a pre-op diagnosis of l4-5 tlif.It was reported that during tlif procedure through quandrant retractors the cage flipped behind the spinal cord when trying to insert it into the disc space due to the inserter getting loose.There was 2 hours surgical delay due to reported product malfunction.Cage had to be retrieved through midline approach.Laminectomy had to be performed in addition to reach the cage.There was no instrument or implant break.Product utilized correctly according to the directions given in the ifu/labeling.No patient symptoms or complications as a result of this event.No further complications were reported.
Additional Manufacturer Narrative
Product analysis #(b)(4) lot# h5132959 after visual and optical examination, the spacer appears to be twisted just past the area that interfaces with the inserter.The damage appears to be the result of torsional overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: N/A
• 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: 11116778
• Report Number: 1030489-2021-00008
• Device Sequence Number: 11687142
• Product Code: MQP
• UDI-Device Identifier: 00885074520582
• UDI-Public: 00885074520582
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: 9192510
• Device Catalogue Number: 9192510
• Device Lot Number: H5132959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other