MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number NAV6550005

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient undergoing olif.The levels mentioned as l5-s1 single side position.It was reported that, the surgeon was placing/inserting a voyager ats awl tap screw 7.5 x 45, when the distal end of the driver broke off.This was the second driver to broke during the same procedure.The distal end of the driver broke off, surgeon indicated that the fragment of the driver remained in the head of the screw and in the patient.No immediate or direct patient impact, case was not delayed for the driver broke once placed the last screw.There was no impact on patient outcome.No further complications reported.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 12818631
• MDR Text Key: 285085254
• Report Number: 1030489-2021-01399
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169754522
• UDI-Public: 00643169754522
• Combination Product (y/n): N
• PMA/PMN Number: K170679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2021

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: NAV6550005
• Device Catalogue Number: NAV6550005
• Device Lot Number: CA18K037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/16/2021
• Date Device Manufactured: 12/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 109 KG