MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	179702000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, patient underwent l5-s1 central decompression surgery with bilateral l5-s1 nerve root decompression, l5-s1 posterior spinal fusion, and l5-si posterior spinal segmental instrumentation.As part of this procedure, patient was implanted with expedium pedicle screws.At a post-operative visit with his surgeon on (b)(6) 2024, patient reported that about two weeks prior to the visit he felt a pop in his low back when he stepped around an object.An x-ray taken at the (b)(6) 2024, post-op visit showed that the left l4 pedicle screw was fractured "at the base of the multiaxial connector." based on the hope that the fusion would nevertheless "proceed to full consolidation," patient's surgeon recommended no surgical intervention at that time.(the surgeon corrected his anatomical nomenclature to l5 in a subsequent visit of (b)(6) 2024, consistent with his operative report of (b)(6) 2024.) at a post-operative visit with his surgeon on (b)(6) 2024, x-rays showed that the anterior displacement of his l4 vertebra on the l5 vertebra had increased from 3 mm (as of the (b)(6) 2024 visit) to 9 mm.Continued observation was again recommended by patient's surgeon.(the surgeon corrected his anatomical nomenclature to l5-s1 in a subsequent visit of (b)(6) 2024, consistent with his operative report of (b)(6) 2024.) at a post-operative visit with his surgeon on (b)(6) 2024, x-rays showed that the spondylolisthesis at l4-l5 had not progressed any further.Continued observation was again recommended by patient's surgeon.(the surgeon corrected his anatomical nomenclature to l5-s1 in a subsequent visit of (b)(6) 2024, consistent with his operative report of (b)(6) 2024.) at a post-operative visit with his surgeon on (b)(6) 2024, x-rays showed that right si pedicle screw had fractured, and the l5-s1 spondylolisthesis had increased to 10 mm.Surgical revision was recommended.On (b)(6) 2024, patient underwent an anterior retroperitoneal surgical exposure of the l5-s1 intervertebral disc space, followed by ls-s1 anterior lumbar interbody fusion with instrumentation, l5-s1 decompression with bilateral l5 nerve decompression, and l5-s1 posterior spinal instrumentation removal and reinstrumentation.This complaint (b)(4) reports the right side adverse event wile the related complaint (b)(4) captures the left adverse event.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.E3: initial reporter is a lawyer.H3, h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SINGLE-INNER SETSCREW
• Common Device Name: FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24012512
• Report Number: 1526439-2026-00022
• Device Sequence Number: 9343726
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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 Catalogue Number: 179702000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male