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	01/14/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient underwent oblique lumbar interbody fusion.Intra-op, the inserter broke.The doctor acknowledged that it was his fault because he levered on the inserter more than the normal use.The broken piece remained inside the patient.The surgeon felt it was unnecessary to remove it since it was contained within the plate.Surgery was completed successfully with only a slight delay of less than 5 minutes.There were no patient complications or symptoms as a result of this event.
Additional Manufacturer Narrative
Product analysis: the threaded portion at the tip of the driver has broken off.Per the reported event, the inserter was overloaded during a bending moment.The broken off portion was not returned for analysis.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: 8304974
• Report Number: 1030489-2019-00112
• Device Sequence Number: 19098608
• Product Code: MAX
• UDI-Device Identifier: 00643169639522
• UDI-Public: 00643169639522
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K152277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: NM15M0981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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