MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TRANSLACE¿ SPINAL TETHERING SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number	8205300
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having revision surgery.Initial surgery of th4-l1 posterior spine fixation was performed on (b)(6) 2018.It was reported that there was  implant protrusion on the dorsal side.The implant is removed and the patient had recovered. there was no patient symptom reported.There were no further complications reported regarding the event.

• Brand Name: TRANSLACE¿ SPINAL TETHERING SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14133399
• Report Number: 1030489-2022-00359
• Device Sequence Number: 2291466
• Product Code: OWI
• UDI-Device Identifier: 00643169726918
• UDI-Public: 00643169726918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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: 12/01/2025
• Device Model Number: 8205300
• Device Catalogue Number: 8205300
• Device Lot Number: CT17F010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female
• Patient Weight: 40 KG