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	10/15/2019
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 underwent scoliotic curve correction after she was diagnosed with scoliosis.Intra-op, when the surgeon performed a huge traction with clamps with the aim of re-aligning the anterio-posterior curve, the tethers got damaged in correspondence to the tensioner.The distal part of the tether was cut as indicated in the surgical technique.Derotation was applied using gripper and applying tension to the clamp.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection revealed the tether was returned into 2 pieces.A visual review of the failure points shares a consistent physical appearance.The tether appears to have been cut straight across.This type of damage is consistent with a the tether coming in contact with a sharp edge or cutting blade.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: 9294245
• Report Number: 1030489-2019-01290
• Device Sequence Number: 14133718
• 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): 03/05/2020

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: 02/04/2020
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1