MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	179712645
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.Investigation summary: the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed an additional blue label with device information was observed.The potential cause for this condition has been confirmed to be due to the label been applied for warehouse logistic.Additionally, only one label with device was observed on image, therefore, the condition of the remaining 30 is unknown.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the si polyaxl screw 6 x 45mm would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history: part#: 179712645, lot#: 236149, batch1: lot qty of (b)(4) units were released on 18.Mar.2019 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported the distribution center has noticed that received products with label different then previous time.Two products were sent to customer before potential issue was discovered.

• Brand Name: SI POLYAXL SCREW 6 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 21988262
• Report Number: 1526439-2025-00592
• Device Sequence Number: 18262714
• Product Code: NKB
• UDI-Device Identifier: 10705034067735
• UDI-Public: (01)10705034067735(10)236149
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179712645
• Device Lot Number: 236149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2019
• 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
• Patient Sex: Unknown