MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 480 MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179762480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Solid Tumour (4552)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a spinal fusion for a metastatic spinal tumors on (b)(6) 2025.The surgery was completed successfully with no delay.After the surgery, it was confirmed that the rod broke.The rod broke cranially on the left l4.Revision surgery took place on (b)(6) 2025.A four-rod construct was successfully constructed using four top notch universal connector pieces, one sfx cross connector piece, one sfx cross connector piece, and one rod diamete piece.Preoperative frontal, preoperative lateral, and postoperative frontal images were taken.The surgeon commented that the patient suffered from metastatic spinal tumors, and it is believed that the fracture of this product occurred due to the weakening of bones caused by the metastatic tumors.The doctor in charge has determined that there is no causal relationship between the health damage and this product.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: h6 (medical device problem code).Updated pec from broken - intra-op to broken post-op.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: h4.Investigation summary = > an analysis of the product could not be performed since a physical sample was not received for 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.Device history lot = > a dhr evaluation was performed for the finished device.Product code: 179762480.Lot number: cskaxj.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 16-jul-2024.Manufacturing site: jabil le locle.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed a sequence of preoperative and postoperative images, in which a rod fracture was observed at the l4 vertebral level.The case was managed by adding two additional rods to the affected area, as demonstrated in the postoperative x-ray.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the rod, 480 mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a dhr evaluation was performed for the finished device.Product code: 179762480, lot number: cskaxj.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 16-jul-2024, manufacturing site: jabil le locle.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ROD, 480 MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 ; SZ
• Manufacturer Contact: elba bello ; chemin blanc 38; le locle ; SZ ; 9083863534
• MDR Report Key: 23349720
• Report Number: 1526439-2025-01324
• Device Sequence Number: 7771047
• Product Code: NKB
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437(10)CSKAXJ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179762480
• Device Lot Number: CSKAXJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 11/28/2025; 03/18/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/01/2025; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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 Age: 79 YR
• Patient Sex: Male