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

Catalog Number	8219500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a correction surgery at t6-l3.Intra-op, after placement was performed, the tethers broke while applying tension with the tensioner.Tension was applied when correction was once performed.After provisional fixation, loosening was performed.And when tension was applied again during the second correction, the tethers broke.Therefore, product from another manufacturer (nesplon) was used.The surgeon wondered whether correction was performed excessively.The broken product was removed with no fragment of the product remaining inside the patient.No patient complications were reported as a result of this event.

• Brand Name: TRANSLACE SPINAL TETHERING SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10052258
• Report Number: 1030489-2020-00522
• Device Sequence Number: 2916483
• Product Code: OWI
• UDI-Device Identifier: 00763000108397
• UDI-Public: 00763000108397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163181
• 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
• Report Date (Section B): 05/13/2020

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 Catalogue Number: 8219500
• Device Lot Number: VS17C001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1