MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 2140010

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2022

Event Type  malfunction  

Event Description

During olif l3 & l4, the threaded tip of medtronic screw driver broke off into the plate that was placed in the patient.The tip is unable to be retrieved as it is embedded into the steel plate.The screw driver has been taken out of service and sequestered.Manufacturer response for medtronic screwdriver, all-in-one inserter (per site reporter).Manufacturer would like the part returned for further examination after investigation is completed.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 14928930
• MDR Text Key: 295320404
• Report Number: 14928930
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022

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: 2140010
• Device Catalogue Number: 2140010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2022
• Date Report to Manufacturer: 07/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White