MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	3600600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider via manufacturing representative regarding patient with unknown indication for spinal therapy.Event occurred during use of the device.It was reported that patient had new cervical occipital pain, one month post op.Admitted through er.Imaging showed the plate and screws had pulled out of the bone.Device explant was planned for (b)(6) 2020.No further patient symptoms or further complications reported.Device will be returned post explant.Update; the explant of the devices was completed on (b)(6) 2020.The procedure was to explant the oc plate, occipital bone screws, rods and set screws (primary surgery was occiput plate, to c3-c5 lateral mass screws).C1 screws were implanted, c6 lateral mass screws implanted, t1 and t2 pedicle screws were implanted, new rods and set screws were implanted.Patient is now recovering and wearing a collar.
Additional Manufacturer Narrative
H3: product analysis #(b)(4):3600600 lot# rm20j012 visual and optical examination identified that one of the locking set screws is missing and there is damage to the backside of the saddles.Unable to determine root cause of the foregoing event from the available information.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFINITY OCCIPITOCERVICAL UPPER THORACIC SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11145037
• Report Number: 1030489-2021-00030
• Device Sequence Number: 846050
• Product Code: KWP
• UDI-Device Identifier: 00643169527423
• UDI-Public: 00643169527423
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K163375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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 Model Number: 3600600
• Device Catalogue Number: 3600600
• Device Lot Number: RM20J012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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: Required Intervention
• Patient Age: 58 YR