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

Model Number	NAV2132
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding patient implanted with a spinal product using an inserter for a l5-s1 tlif extension and revision of hardware at l3-l5.It was reported that the side metal pieces of the elevate inserter that hug the elevate cage broke off.According to the physician, both pieces were extracted.The instrument broke and there was no fragment of the instrument remaining in the patient's body.There were no patient symptoms or complications as a result of the event.The product was used in operation field and came in contact with the patient.The pre-op diagnosis was lumbar instability neurogenic claudication due to lumbar spinal stenosis and levels implanted were l5-s1.There was no treatment or additional surgery performed as a result of this event.The product was replaced by a medtronic product.The patient's medical history included diabetes, blood pressure, arthritis.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
D4: updated udi# h3: product analysis part# nav2132, lot# dn19h001- visual and optical inspection confirmed that both of the prongs at the tip of the inserter have been broken off.This type of damage is consistent with bend stress overload.H6: updated eval.Code method and eval.Code result post analysis medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12230511
• Report Number: 1030489-2021-00973
• Device Sequence Number: 3036410
• Product Code: OLO
• UDI-Device Identifier: 00643169771000
• UDI-Public: 00643169771000
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K163581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2021

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: NAV2132
• Device Catalogue Number: NAV2132
• Device Lot Number: DN19H001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 94 KG