MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number SEE H10

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

Patient Problems Neuropathy (1983); Pain (1994)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery: 1) product id: 6661036, lot#: 0569184w, 510(k): k172199, udi: (b)(4), product code: max, qty: 1.2) product id: 6661136, lot#: 0591366w, 510(k): k172199, udi: (b)(4), product code: max, qty: 1.3) product id: 54840006550, lot#: h5337223, 510(k): k091974, udi: (b)(4), product code: nkb, qty: 1.4) product id: 54840006540, lot#: h5307510, 510(k): k091974, udi: (b)(4), product code: nkb, qty: 1.5) product id: 5440030, lot#: h5351674, 510(k): k102555, udi: (b)(4), product code: nkb, qty: 1.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.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: instability (up to and including grade 2 spondylolithesis, retrolisthesis or lateral listhesis) no.Of levels treated: 2 it was reported that the patient underwent a surgery.Post-op, on (b)(6) 2018, the patient experienced increased right leg pain that radiated into the lateral thigh.Investigation noted the event to be non-serious.The investigator determined the adverse event to be possibly related to surgical procedure, interbody device, multiaxial screws, rods and set screws.The outcome of the adverse event was pending.

Manufacturer Narrative

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

Event Description

According to the sponsor assessment, the adverse event was noted to be possibly related to interbody device, multi-axial screws, rods and screws.No relatedness with the surgical procedure was found.The patient also underwent an additional surgery on (b)(6) 2019.Anterior lumbar interbody fusion was performed at l2-l3 via trans psoas left-sided approach.Attachment was made to prior l3-l5 construct.

Manufacturer Narrative

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

Event Description

The outcome of the adverse event was resolved on (b)(6) 2019.According to the sponsor assessment, the adverse event was considered as non-serious.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Relatedness of the additional surgical procedure to surgical construct and/or the study procedure: not related.

• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8077150
• MDR Text Key: 127340210
• Report Number: 1030489-2018-01495
• Device Sequence Number: 1
• Product Code: MAX
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 69