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 Pain (1994)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery: product id: 7510200, lot#: m111814aah, qty.: 1, pma: p000054, udi: (b)(4).Product id: 55840007550, lot#: h5537669, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007545, lot#: h5502028, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007545, lot#: h5560411, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007545, lot#: h5498604, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007545, lot#: h5558356, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 5540030, qty.: 4, 510(k): k113174, udi: (b)(4).Product id: 56351310, lot#: ca18k043, qty.: 1, 510(k): k171689, udi: (b)(4).Product id: 56351310, lot#: ca19a042, qty.: 1, 510(k): k171689, udi: (b)(4).Product id: 7800320, lot#: cccn19h7, qty.: 2, 510(k): k082166, udi: (b)(4).Product id: 1555501070, lot#: 0720330w, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 5540030, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 5540030, lot#: h5558968, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 1555501070, lot#: 0711774w, qty.: 1, 510(k): k113174, udi: (b)(4).Product id: 55840007550, lot#: h5537673, qty.: 1, 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 spondylolisthesis, retrolisthesis or lateral listhesis with documented pre-operative instability at 3 levels.On (b)(6) 2019, the patient underwent spinal surgery at l2-s1.Rods, screws, rhbmp-2/acs, grafts were implanted in the patient during this surgery.With an onset date of (b)(6) 2019, patient experienced severe back pain and left leg pain 4 days post-op surgery.Emergency room visit, drug therapy, follow up with neurosurgery as scheduled were 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 not related to interbody fusion, grafting material, posterior fixation; possibly 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, procedure and surgical procedure.Diagnostic tests performed on (b)(6) 2019: (1) posterial fluid collection <(>&<)> epidural venous distention resulting in increased effacement of the thecal sac at l4-l5 <(>&<)> l5-s1 with crowding of the cauda equina.(2) mri- l-spine-5., which showed normal results.The outcome of this adverse event is pending.

• 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
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9915520
• MDR Text Key: 189630742
• Report Number: 1030489-2020-00408
• 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,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• 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: 03/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2018
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 100