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

Catalog Number 2161001

Device Problem Break (1069)

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

Event Date 11/12/2018

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

It was reported that intra-op, the shaft broke at the tip.The product came in contact with the patient.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product analysis: visual review confirms the instrument is broken several threads down from the distal tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fracture with no indication of torsion or fatigue.There is a sheer lip that is consistent with bend stress overload.Conclusion: the above observations are consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8173064
• MDR Text Key: 130618879
• Report Number: 1030489-2018-01664
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639607
• UDI-Public: 00643169639607
• 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,Followup
• Report Date: 05/24/2019

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 Catalogue Number: 2161001
• Device Lot Number: NM15L0921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2017
• 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