MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC OTHER EXTRA-DISCAL; SCREWDRIVER

Model Number 815-517

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a spinal product using drivers for a posterior fusion and corpectomy.It was reported that the driver tips sheared off during hardware removal.Broken fragments were recovered and alternative instruments used.The instruments broke and there were no fragments of the instruments remaining in the patient's body.The driver broke during the extension/revision surgery.We used alternative drivers to remove the implants.There were no patient symptoms or complications as a result of the event.The patient came in contact with the instruments.The pre-op diagnosis was extension/ revision of fusion.The levels implanted were t4-t9.There was no treatment or additional surgery performed as a result of this event.Medtronic products were used in the initial surgery and had no malfunction that resulted in the revision surgery.Patient suffered subsequent injury after initial surgery and required additional stabilization.The products will be replaced by medtronic products in the future.The patient's medical history includes obesity.No further complications were reported/ anticipated.

• Brand Name: OTHER EXTRA-DISCAL
• Type of Device: SCREWDRIVER
• 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: 10827398
• MDR Text Key: 216140273
• Report Number: 1030489-2020-01634
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00673978045085
• UDI-Public: 00673978045085
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 815-517
• Device Catalogue Number: 815-517
• Device Lot Number: KH18E450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 159