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

Model Number 8205300

Device Problem Expulsion (2933)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 289422996
• Report Number: 1030489-2022-00359
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00643169726918
• UDI-Public: 00643169726918
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8205300
• Device Catalogue Number: 8205300
• Device Lot Number: CT17F010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 40 KG