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

Catalog Number SEE H10

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

Patient Problem Neuropathy (1983)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery: product id: p1603m, lot#: mx99382aap, qty.: 1.Product id: 55840007560, lot#: h5568769, qty.: 2, 510(k): k113174, udi: (b)(4).Product id: 55840007555, lot#: h5557395, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 5540130, lot#: h5556147, qty.: 4, 510(k): k113174, udi: (b)(4).Product id: 5540130, lot#: h5436979, qty.: 4, 510(k): k113174, udi: (b)(4).Product id: 1553201080, lot#: unk, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 7510200, lot#: m111814aah, qty.: 1, pma: p000058, udi: (b)(4).Product id: 2990726, lot#: h5079379, qty.: 1, 510(k): k073291, udi: (b)(4).Product id: 2990726, lot#: h5519434, qty.: 1, 510(k): k073291, udi: (b)(4).Product id: 7800320, lot#: cccn19h7, qty.: 2, 510(k): k082166, udi: (b)(4).Product id: 1553201090, lot#: 0576966w, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007550, lot#: h5526815, qty.: 2, 510(k): k113174, udi: (b)(4).Product id: 55840007560, lot#: h5554204, qty.: 3, 510(k): k113174, udi: (b)(4).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

It was reported as per clinical study that the patient presented with stenosis with documented pre-operative instability at 3 levels.On (b)(6) 2019, the patient underwent fusion at 3 levels.Rods, screws, 4.2 mg rhbmp-2/acs, grafts were implanted in the patient during this surgery.With an onset date of (b)(6) 2019, right sided l4-l5 radiculitis was reported.Hence, on (b)(6) 2019, decompression was performed at levels l2-l3, l3-l4, l4-l5 and l5-s1.There was stenosis at l2-l3 and hematoma that was compressing the l3-s1 thecal sac in the region of prior decompression.All of the thecal sac was fully decompressed with no remaining hematoma.Drug therapy was also performed as a part of intervention for this adverse event.The investigator noted the adverse event as non-serious.Site related assessment noted that the adverse event was unlikely related to interbody fusion, grafting material, posterior fixation; probably related to surgical procedure; and related to surgical construct and/or study procedure.However, according to sponsor assessment, the adverse event was possibly related to rhbmp-2/acs, grafting kit; and causally related to the surgical procedure.X-ray was performed on (b)(6) 2020, which showed normal results.The outcome of this adverse event is pending.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient presented for an office visit on (b)(6) 2020.The outcome of the adverse event is now resolved with an outcome date of (b)(6) 2020.

Event Description

Updated information received on 04 feb 2021: description: lumbar radiculitis/ radiculopathy interventions: action subtype: drug therapy action result: y action subtype: injection action result: y medication 1: medication name: dexamethasone injection date: (b)(6) 2021 levels: l2-l3, details: 10 mg / 2 cc medication 2: medication name: lidocaine injection date: (b)(6) 2021 levels: l2-l3, details: 1% / 4 cc action subtype: other revelant actions action result: y diagnostics: action type: diagnostic action subtype: l-spine xray-1 action result: normal action date: 2020-01-02 action type: diagnostic action subtype: ct l-spine-2 action result: abnormal action date: (b)(6) 2020 action info: diagnostic tests performed: lumbar stenosis with neurogenic claudication narrative: right sided axial back pain with increase in activity occasional radiation to buttock.Usade/uade assessment: no could dd have led to sade?: not applicable.

Manufacturer Narrative

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.

• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 9615738
• MDR Text Key: 178331400
• Report Number: 1030489-2020-00096
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 106