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 Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the or, when fixing the rod, the expedium verse correction keys were placed by a facilitator tube, as prescribed by the stg.While tightening these correction keys, metal came off the screw head and the correction key no longer had a grip.Subsequently, a unitized set screw was placed.It also had no grip and kept turning.Also two other screws in the construction of a total of 6 screws, gave the same problem: overturning the expedium verse correction keys and the subsequent unitized set screw; as a rescue option.All three screws were then explanted and replaced by new ones.Because of this incident, the operating area had to be checked extra for metal residues.No other metal remains were found.All metal residues found have been removed.By changing the broken screws, there has been a considerable delay in the total or time.Also, 3 extra implants had to be used to bring the or to a successful conclusion.
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.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: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50147986
• Report Number: 1526439-2026-01172
• Device Sequence Number: 18792418
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149(17)310228(10)L37041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2026

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
• Device Lot Number: L37041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 08/06/2026; 09/29/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/12/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2026
• 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