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

Model Number	NAV2133
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
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 broke/damaged due to misalignment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with an indication of stenosis.It was reported that during tlif procedure the tip of the inserter broke off while implanting the elevate cage, and upon inspection after the case, the inner locking tube was bent at the tip and there was no device breakage with inner locking tube.No fragment of the device remaining in the patient.Levels implanted l4-5.No patient symptoms or complications as a result of this event.No additional surgery or treatment performed as a result of this event.Product utilized correctly according to the directions given in the ifu/labeling.No further complications were reported.It was reported that there was not much delay in surgery due to product malfunction.No further complications were reported.It was reported that there was surgical delay of 10 minutes.

• 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: 11953871
• Report Number: 1030489-2021-00746
• Device Sequence Number: 19934248
• Product Code: OLO
• UDI-Device Identifier: 00643169771024
• UDI-Public: 00643169771024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/08/2021

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 Model Number: NAV2133
• Device Catalogue Number: NAV2133
• Device Lot Number: EM17D032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1