MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number P1603LII

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Pain (1994)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Other - neuropathic pain d4/g5: the following products were used in the surgery: product id: 7510800, lot: m111804aaa (x2), pma: p000058, udi: (b)(4).Product id: 55840006545, lot: 5563767(x3), 5567563(x3), 510k: k113174, udi: (b)(4).Product id: 55840007540, lot: 5473525(x2), 510k: k113174, udi: (b)(4).Product id: 5630724, lot: h5591342(x4), h5593765(x4), 510k: k191066, udi: (b)(4).Product id: 1608451090, lot: 74jp(x2), 510k: k191066, udi: (b)(4).Product id: p1603lii, lot: mx92811aap (x1) product id: p1603mgs, lot: cccn19h7(x2).Although it is unknown whether these products caused or contributed to the reported event, we are filling this mdr for notification purpose.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

Pre-op diagnosis: recurrent disc herniation procedure: posterior lumbar fusion (plf) number of levels to be treated: 3 levels (from l2- s1) it was reported that post-op, patient complained right leg pain starting 1 month post-operative; which radiated into right posterol ateral thigh, lateral leg & foot into the 3rd & 5th toes.Patient reports that pain is now worse & increases with ambulation.Patient had lower spine ct w/o contrast today which showed instrumentation in good position with no acute findings.Pain is thought to be a neuropathic pain possibly from nerve manipulation during surgery and should gradually resolve.Sponsor relatedness assessment: this event is possibly related with bone morphogenic protien and the surgical procedures.Event is not related with the surgical con struct/devices.Site relatedness assessment: relatedness with surgical construct and/or study procedure- related relatedness with surgical procedure- possible outcome status: pending.

Event Description

Updated information received on 08-mar-2022: outcome status resolved outcome date: (b)(6) 2021.Pregnant since last visit 24 months: has the subject become pregnant since last visit: no date of visit: (b)(6) 2022, usade/uade assessment: no.Dd have led to sade: not applicable.

Manufacturer Narrative

Updated information added in b5 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: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• 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: 10172874
• MDR Text Key: 195718546
• Report Number: 1030489-2020-00665
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: P1603LII
• Device Catalogue Number: P1603LII
• Device Lot Number: MX92811AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White