MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION VU APOD PRIME NANOMETALENE; GRAFT BLOCK

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

Patient Problem Neuropathy (1983)

Event Date 08/16/2022

Event Type  Injury  

Manufacturer Narrative

The root cause was not determined.It was reported that the patient developed left lower extremity weakness to l4-l5 and l5-s1, that was probably related to the surgical procedure and required intervention to prevent permanent impairment.Surgical treatment was performed on (b)(6) 2022 for mis left l4-l5, l5-s1 foraminotomies and posterior decompression.Whether the left lower extremity weakness experienced by the patient was the result of the procedure performed is unknown.Post-op day 1, the patient reported lle pain and weakness is improving.

Event Description

Patient developed left lower extremity weakness.This is in part due to the clinical decision making process to determine best approach for surgery.

• Brand Name: VU APOD PRIME NANOMETALENE
• Type of Device: GRAFT BLOCK
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15384629
• MDR Text Key: 299552349
• Report Number: 3012120772-2022-00028
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OSTEOSTRAND PLUS
• Patient Outcome(s): Required Intervention