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

Catalog Number 2140010

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2017

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.

Event Description

It was reported that patient underwent an oblique lumbar inter-body fusion surgery (olif) at l3-l4.Intra-op, inserter's screw at the tip was broken.The broken piece was stuck inside the locking cap of the cage.Surgeon was unable to twist the locking cap with the screw driver as the broken piece was stuck in the middle of the locking cap.No patient complications were reported as a result of the event.

Manufacturer Narrative

X-ray review images for l3-4, l4-5, l5-s anterior lumbar fusion was provided.On the magnified image at l3-4, there is an opacity in the locking cap presumably a broken piece of the plate inserter.It is unclear if this is related to technique or a defect in the inserter release mechanism.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7026506
• MDR Text Key: 91877687
• Report Number: 1030489-2017-02321
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639522
• UDI-Public: 00643169639522
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2140010
• Device Lot Number: NM16E086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2016
• 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