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 Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Product was not 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 the patient was pre-operatively diagnosed with degenerative disc disease at l4/5 and underwent oblique lumbar interbody fusion at l4/5.During the surgery, the tip of the threaded inserter broke.During insertion under x-ray, when the cage was approximately ¾th of the way across the disc space, the inserter became detached from the implant.Upon inspection of the inserter it was clear that the tip has broken off from the internal threaded inserter.It has broken off flush with the articulating section of the implant.The surgeon tried to use needle holders to remove the broken fragment but was unable to remove.The product came in contact with the patient.Fragment of the products were remained in the patient.No patient symptoms or complication were reported.No additional treatment or surgery performed as the result of the event.

Manufacturer Narrative

Radiographic image review: post-op x-rays for l4-l5 olif show satisfactory placement of interbody graft.By report, the threaded inserter broke of in the interbody graft.In the provided images, there are no metal fragments outside interbody space in the field of view.The tip is presumably still in the interbody graft and should not interfere with the performance of the device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis visual review confirmed the instrument is broken several threads down from the tip of the threaded rod.No surface defect identified that could contribute to crack propagation.Microscopic examination of the fracture surface finds a fairly brittle fracture with no indication of torsion or fatigue.There is a shear 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: 8202640
• MDR Text Key: 131602788
• Report Number: 1030489-2018-01707
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639607
• UDI-Public: 00643169639607
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2161001
• Device Lot Number: NM18G004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 77