MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PIVOX OBLIQUE LATERAL SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 2161001

Device Problem Break (1069)

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

Event Date 10/01/2020

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 provider (hcp) via manufacturer representative regarding a patient for unknown spinal the rapy.It was reported that when surgeon was implanting the cage with inserter, and then backed the implant out.He removed the implant from the inserter on the back table, the tip of the inserter broke off in the implant.There was patient involved in the event and no further complications were reported.Additional information was received on (b)(6) 2020: when the surgeon removed the inserter from the implanted implant, the tip broke off during removal.The broken off piece was left in the cage, and was easily removed by the surgeon with some pickups.The part number of the inserter was 2161001.There were no complications involved to the patient.The patient outcome was as planned with no delay in the case.No fragments left inside.They took c-arm shot to confirm.This was happened during the case.The product came in contact with the patient.Additional information was received on (b)(6) 2020: there were no problems with the implant/cage.The lot number of the reported inserter is unknown.Additional information was received on (b)(6) 2020: yes, there was no injury to the patient, and the outcome of the case was just how the surgeon planned it pre-op.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 10768308
• MDR Text Key: 214083497
• Report Number: 1030489-2020-01528
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152277
• 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: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2161001
• Device Catalogue Number: 2161001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1