MAUDE Adverse Event Report: UNKNOWN UNKNOWN

Model Number UNKNOWN

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

Patient Problems Inflammation (1932); Muscle Weakness (1967); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation as it remains in-situ.No conclusions can be drawn at this time.If any additional information is provided, a supplemental report will be submitted.

Event Description

Information was received that a revision procedure was performed on (b)(6) 2020 to exchange the temporary arthrodesis screw for a new screw.Immediately following the procedure on (b)(6) 2020 the patient reportedly experienced soreness from the screw removal in the ankle, significant muscle weakness and soreness, and discomfort in the left ankle with sanguineous drainage from the heel from the osteotomy site after a suture popped one week post-op.There was no active bleeding reported.The patient reportedly experienced severe pain that interrupted their sleep which was treated with naproxen.Additionally, the patient reported experiencing pain in the knee due to the tibial screw, tenderness on the ankle, and a possible infection which was being checked regularly by the physician's assistant.An explant procedure to remove the screw is planned for an unknown date once the patient's lengthening have been completed.

Event Description

No additional information received.

Manufacturer Narrative

Review of the provided information revealed that the screw that caused the adverse event was not manufactured by nuvasive.The report submitted was not needed.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 15583739
• MDR Text Key: 301566125
• Report Number: 3006179046-2022-00254
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female