MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. 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 Bacterial Infection (1735); Purulent Discharge (1812); Inflammation (1932); Necrosis (1971); Skin Discoloration (2074); Burning Sensation (2146); Metal Related Pathology (4530); Localized Skin Lesion (4542)

Event Type  Injury  

Event Description

Information was received that the patient developed a "skin eruption" and metal reaction.A cleansing and debridement procedure was performed on (b)(6) 2021.The reaction seems to be due to an oily substance found round the top portion of the actuator of the rod.Additionally, it was reported that there was discoloration of the surrounding tissue.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Additional information received from the surgeon: both cultures were taken from deep tissue, around magnet area, on the two separate times patient went to or, first for the cleansing, later for removal.The devitalized tissue created a sinus tract into the skin, which ulcerated and thus making the contamination (enterococcus faecalis) possible.Enterococcus faecalis likely from cross contamination when skin erupted (organism not typical from surgical site infection 3 years ago).Device evaluation: the returned rod was observed to be partially distracted with score marks and debris on the distraction rod.The rod was functionally tested and could not distract or retract with the external remote controller (erc) or the manual distractor.As a part of the investigation, the work order was reviewed and confirmed the device passed all inspections.X-ray images of internal components revealed a broken radial ball bearing.The cause of the broken radial ball bearing is unknown.The rod was sectioned and debris build-up was found in the rod.Rod contouring and/or patient activity may have applied loading onto the rod and contributed to wear debris generation; however, the volume of debris does not appear to correspond to the volume of observed material loss from the device components.Additionally, the o-ring component could not be identified in the sectioned rod.Therefore, body fluid may have been able to enter/exit the internal housing tube space and may have contributed to the observed degree of debris build-up.No oily substance was found inside the actuator; therefore, it cannot be confirmed that the reported oily substance originated from the actuator.The cause of the reported "skin eruption", metal reaction, and tissue discoloration cannot be determined and no direct correlation to device materials of construction can be made.Based on the available pre-clinical and clinical information and the fact that the main external components of the magec rods are manufactured from a titanium alloy, which has successfully been used for decades in implantable medical devices, the biocompatibility-related risks are considered to be low in general.Device records review: review of the device history records revealed no discrepancies related to this complaint.The rod was manufactured in accordance with the specified requirements and met all of the required quality inspection criteria prior to release.

Manufacturer Narrative

Additional information was received via medwatch that in 2020, the patient complained of a burning-like sensation in their back.The patient's parents later observed a big bump in the center of their back.They were concerned of chemical exposure.The surgeon suspected it to be a bursitis due to friction of the rod with the tissue and prescribed an anti-inflammatory.The bump decreased except for one circular bump in the center.It changed in color from normal skin to very dark red and was suppurating.The wound was drained and the surgeon prescribed cephalexin for 2 weeks.In 2021, the patient's parents sent a photo of the wound to the surgeon as it turned black and continued suppurating.The patient was treated with silver nitrate twice a week as well as oral antibiotics (clindamycin, cefdinir, and amoxicillin).The patient underwent a revision to clean the wound in which they were noted to have necrotic tissue that went from the outer skin all the way down to the rod.During the explant procedure, bone tissue was surrounding the rod which required bone to be cut and removed in order to extract the rod.The patient was treated with iv ampicillin, gentamicin sulfate and meropenem for 6 weeks.

Event Description

See h10.

• Brand Name: MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM - MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr, suite 100; aliso viejo, CA 92656
• MDR Report Key: 12691591
• MDR Text Key: 280744645
• Report Number: 3006179046-2021-00488
• Device Sequence Number: 1
• Product Code: PGN
• UDI-Device Identifier: 00812258026332
• UDI-Public: 812258026332
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A171002-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 03/25/2022
• Supplement Dates FDA Received: 01/09/2022; 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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; Hospitalization
• Patient Age: 9 YR
• Patient Sex: Male