MAUDE Adverse Event Report: NEO MEDICAL SA NEO PEDICLE SCREW SYSTEM - PEDICLE SCREW KIT 2X(Ø8.0 X 50MM); THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	PEDICLE SCREW KIT 2X(Ø8.0 X 50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event description: revision surgery performed on (b)(6) 2024 after 10 months from initial surgery due to pain and disconnected of the screw head from the screw shaft on the level l5 on both sides.A second surgery took place after the revision surgery to implant an interbody fusion cage on l4 v initial surgery performed on (b)(6) 2023 with monoaxial screws sc-80-50-pe (on level l4 sc-80-55-pe (2021046031) and rd-00-90-pb (2020035136)).Complaint investigation: the x-ray after the first surgery in (b)(6) 2023 looks fine (no screw breakage or disconnection).The patient was supposed to get a follow-up visit scheduled at 6 weeks for x-ray control but he did not show up.At that time the surgeon also planned a second surgery to add the anterior support surgery (adding a cage).Only after 10 months the patient came to the hospital with pain and the problem leading to a the first revision surgery.No fusion could be seen at the 10 month x-ray.In case a cage is not placed a fusion will not occur.As stated in ifu for neo pedicle screw system: "the neo pedicle screw system¿ is intended to help provide immobilization, correction and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine." as also stated in a warning in the ifu: "the implants are not prostheses.In the absence of fusion, the instrumentation and/or one or more of its components can be expected to pull out, bend, or fracture as a result of exposure to every day mechanical stresses." from what we have understood is that the patient is a construction worker in germany, 180 cm tall,110 kg weight, and it is likely he has gone back to work earlier, thus not adhering to what is stated in ifu on post-operative care: "detailed instructions on the use and limitations of the device should be given to the patient.If partial weight-bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening and/or breakage of the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity.The risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated or demented.The patient should be warned to avoid falls or sudden jolts in spinal position.To allow the maximum chances for a successful surgical result, the patient or devices should not be exposed to mechanical vibrations or shock that may loosen the device construct.The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation." neo medical also looked at the batch production records for the affected lot, the report concluded: "the tracing of the batch, the inspection of the assembly curve, the evaluation of the test characteristics and the review of the non-conformities did not identify any anomalies attributable to the defect pattern." by checking the returned explanted screws the taper connection is intact and free of corrosion or damage (see additional comments below) our conclusion is that the implant failure was caused by the lack of fusion due the lack of implantation of a interbody fusion cage, which is a result of poor patient compliance as not showing up for the follow-up visit.

• Brand Name: NEO PEDICLE SCREW SYSTEM - PEDICLE SCREW KIT 2X(Ø8.0 X 50MM)
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEO MEDICAL SA; route de lausanne 157a; villette (lavaux) vaud, 1096 ; SZ 1096
• Manufacturer Contact: jonas larrson ; route de lausanne 157a,; villette, 1096 ; SZ 1096
• MDR Report Key: 19949667
• Report Number: 3013546462-2024-00001
• Device Sequence Number: 8810265
• Product Code: NKB
• UDI-Device Identifier: 07640177820693
• UDI-Public: 07640177820693
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: PEDICLE SCREW KIT 2X(Ø8.0 X 50
• Device Catalogue Number: SC-80-50-PE
• Device Lot Number: 2023059778
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RD-00-90-PB; SC-80-50-PE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 110 KG