MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ELEVATE¿ SPINAL SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	NAV2133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
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 open transforaminal lumbar interbody fusion (tlif) at l3-5 due to spinal stenosis.Post-op, it was noticed that the very distal-most tip, approximately 3-4 threads worth, of the inner inserter tube had been sheared off.Surgeon was unable to affix the implant for 10-14 case onto the inserter.Surgeon believed that the metal fragment was floating lose inside the patient, so an o-arm imaging scan was performed immediately post op per normal protocol to verify placement of all instrumentation.Nothing abnormal was observed floating lose in the patient.The instrument was hand washed post-operatively and placed back into its location in the set then the entire set machine washed, then wrapped and sterilized.There were no patient complications as the result of this event.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed about 2 threads have been broke off.There are no signs of the locking tube being bent.It appears the threads were broken/damaged due to misalignment.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ELEVATE¿ SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 9314487
• Report Number: 1030489-2019-01301
• Device Sequence Number: 2615851
• Product Code: OLO
• UDI-Device Identifier: 00643169771024
• UDI-Public: 00643169771024
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K163581
• 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): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NAV2133
• Device Lot Number: EM17L038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR