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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: 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 post-op, translace bands snapped at some point.Hence, on (b)(6) 2019 a revision surgery was preformed due to translace breakage.No patient complications were reported due to this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Patient underwent neuromuscular pediatric scoliosis correction at upper thoracic level between t4-t8.

• Brand Name: TRANSLACE SPINAL TETHERING SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9225060
• Report Number: 1030489-2019-01195
• Device Sequence Number: 11294080
• Product Code: OWI
• UDI-Device Identifier: 00763000108397
• UDI-Public: 00763000108397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2019

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 Catalogue Number: 8219500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/17/2019
• 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: Required Intervention
• Patient Weight: 26