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

Model Number 8219500

Device Problem Break (1069)

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

Event Date 04/14/2021

Event Type  malfunction  

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 via a manufacturer representative regarding a patient who was implanted with a spinal product type for adjacent joint disease.It was reported that when attempted to apply tension to the tether, the tether broke at the tensioner lever fixing part.It did not try to reset it but pulled the tether according to the manual to perform the final tightening and the tether was continued to be implanted as it was.There was delay of less than 60min in overall procedure time.There were no fragments of instrument left in the patient body.No health damage in the patient was reported.

• Brand Name: TRANSLACE SPINAL TETHERING SYSTEM
• 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: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11775897
• MDR Text Key: 249089608
• Report Number: 1030489-2021-00570
• Device Sequence Number: 1
• Product Code: OWI
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 8219500
• Device Catalogue Number: 8219500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1