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 01/14/2019

Event Type  Injury  

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 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.

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
• 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: 8304974
• MDR Text Key: 135000665
• Report Number: 1030489-2019-00112
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00643169639522
• UDI-Public: 00643169639522
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• 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: NM15M0981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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