MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CC STRGT ROD 6.0 X 480MM HEXHEX; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number	5560602480C
Medical Device Problem Codes	Device-Device Incompatibility (2919); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date the rod was slipping on a trialtis screw.The patient's post op ct and the rod on the left distal side had slipped.Patient doing fine.Surgeon is monitoring closely.All available information has been disclosed.No further information was provided.
Additional Manufacturer Narrative
Product complaint #(b)(4).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.D1, d2, d3, d4, g4-510k: this report is for an unk rods/unknown lot.Part and lot number are unknown.Without the specific part number, the udi number and 510-k number is unknown.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: a2, a3a, b3, b5, d4 (catalog), d10 concomitant, e1 facility name corrected: d1, d4 (primary udi number), g1, h6 (health effect - impact code, health effect - clinical code & medical device problem code) h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary = > product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, 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.
Event or Problem Description
Additional information received states that t2-l2 psf, implanted the rods and final tightened.Next day patient got post op ct and the rod on the left distal side had slipped about 5mm proximally.Using trialtis and 6.0 cobalt.Chrome rods.The surgery completed successfully and the patient is doing fine.

• Brand Name: CC STRGT ROD 6.0 X 480MM HEXHEX
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): CARAGH PRECISION; parkmore business park west; galway H91 C H05; EI H91 CH05
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21297084
• Report Number: 1526439-2025-00172
• Device Sequence Number: 12706615
• Product Code: MNH
• UDI-Device Identifier: 10705034596471
• UDI-Public: (01)10705034596471
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 5560602480C
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POLY SCREW, SOLID, 7.5MM X 50; POLY SCREW, SOLID, 7.5MM X 50; SET SCREW T27
• Patient Age: 17 YR
• Patient Sex: Male