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

Catalog Number	2140010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Image review- the submitted images appear to display broken threaded shaft.
Event or Problem Description
It was reported that the patient underwent direct lateral interbody fusion at l2-5 using standard lateral approach due to spinal stenosis and degenerative disc at l2-5.During the surgery, the piece of the all-in-one-inserter that threads into the interbody to retain it to the inserter broke off in the implant.The fragment could not be removed from the interbody.No patient complications were reported as the result of the event.
Additional Manufacturer Narrative
Product analysis- the inserter was returned with approximately 11.5mm of the threaded tip broken off.The fractured section was the threaded portion of the tip that interfaces with the interbody device.There were witness marks located on the backside of the inserter where it was impacted during use.A microscopic review of the fracture surface reveals little to no surface smearing or signs of cyclic fatigue.The material disruption on the face of the fracture is consistent with mechanical overload from a bending moment.Out of tolerance specification was not noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIVOX OBLIQUE LATERAL SPINAL SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 6766346
• Report Number: 1030489-2017-01862
• Device Sequence Number: 13944920
• Product Code: MAX
• UDI-Device Identifier: 00643169639522
• UDI-Public: 00643169639522
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2140010
• Device Lot Number: NM17B038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR