MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TRANSLACE SPINAL TETHERING SYSTEM

Catalog Number	8219500
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: owi: bone fixation cerclage, sublaminar.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented with scoliosis; and underwent spinal fusion, sagittal re-alignment and derotation.Intra-op, during curve correction, while tensioning the tether, the instrument started damaging the tissue of the tether; hence, the physician had to stop applying tension.Then, the damaged distal part of the tether was cut and removed.The broken part did not remain inside the patient.Reportedly, a very good correction of the scoliotic curve could not be performed due to this event; however, no patient complications were reported.
Additional Manufacturer Narrative
Product analysis: the tether cables have been returned torn/separated in several different locations.A visual review of the failure points shares a consistent physical appearance.There is necking around and leading up to the point of separation.This type of damage is consistent with a pulling force being applied to the material leading to the material overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRANSLACE SPINAL TETHERING SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9428825
• Report Number: 1030489-2019-01385
• Device Sequence Number: 479729
• Product Code: OWI
• UDI-Device Identifier: 00763000108397
• UDI-Public: 00763000108397
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K163181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 05/08/2026
• Device Catalogue Number: 8219500
• Device Lot Number: VS18C001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR