MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	199721001S
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 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.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 that a posterior spinal fusion (lumber 2-5) for adult spinal deformity on (b)(6) 2025 was performed.L2-sai was fixed for asd.Llif had been performed on l2/3/4/5 a week ago.From the posterior side, plif of l5/s and posterior fusion of l2-sai were performed.In the surgery, after inserting the sai and verse screw, the rod and set screws were placed, and applied final of the set screw was performed from the sai.From s1, after finalizing the lower part, the surgeon finalized while applying compression to the upper part.Finals were performed on all set screws.Later, while using a special instrument to break off the screw's reduction tab, the surgeon and his assistant noticed that the screw head was loose.Therefore, the surgeon again applied compression and finalized the set screws.The surgeon confirmed that the set screws were not floating away from the screw head and completed the surgery.The surgery was completed successfully without any surgical delay.
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: d10 (concomitant) 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.

• Brand Name: 5.5 EXP VERSE UNITIZED SET SCR
• 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: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 21696464
• Report Number: 1526439-2025-00416
• Device Sequence Number: 21159159
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,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: 199721001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN SCREWS
• Patient Sex: Unknown