MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM - MAGNETIC ACTUATION

Model Number MS1-4570S

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

Patient Problems Purulent Discharge (1812); Fever (1858); Pain (1994); Drug Resistant Bacterial Infection (4553); Decreased Appetite (4569)

Event Date 12/07/2020

Event Type  Injury  

Event Description

Information was received that the patient began to develop increased back pain, decreased appetite, and unexplained intermittent fevers after an implant procedure.Additionally, it was reported that there was displacement of the internal fixation device of the vertebrae and the surgery area had become raised and expressed some purulent damage.The patient was admitted to the hospital on (b)(6) 2020 and diagnosed with an infection and inflammatory reaction due to the internal fixation device in the spine.During the revision, purulent material/drainage was found along the rod tracks and into the screws and four proximal screws were found to be grossly loose.The patient underwent irrigation and debridement and had a wound vac placed.The patient was also reported to have experienced a dural tear in the lumbar region which was repaired intraoperatively.Following the revision, the patient was found to have acute posthemorrhagic anemia and also developed contact dermatitis at the spinal incision.The patient was given iv antibiotics for six weeks and later transitioned to oral antibiotics.Additionally, the patient experienced edema and atelectasis.Following revision, the patient was found to have residual thoracic dextroscoliosis and localized kyphosis at the thoracolumbar region.Patient is now in a brace and awaiting a final fusion.

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

Manufacturer Narrative

Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

Event Description

Additional information has been provided.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS; 101 enterprise dr, ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS; 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: 13608128
• MDR Text Key: 290544158
• Report Number: 3006179046-2022-00131
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS1-4570S
• Device Lot Number: 0052928AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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): Hospitalization; Other
• Patient Age: 10 YR
• Patient Sex: Female