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

Catalog Number	199721001
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
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.H11 additional narrative: e3: reporter is a j&j employee.D9, h3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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 this was a posterior spinal fusion (l2) performed on (b)(6) 2023, with vbs+verse.Three months after surgery, it was installed without problems.Six months postoperatively, breakage of the screw in question and loosening of the contralateral set screw were observed.On (b)(6) 2024, the second surgery was performed to remove the screw and the set screw.The surgery was completed successfully with no surgical delay.No further information is available at this time.This report is for one (1) 5.5 exp verse unitized set scr this is report 6 of 9 for complaint (b)(4).
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.H11 additional narrative: h2: corrective data: d4.D2b.: mnh, kwq, mni, osh, kwp.H3, h6: investigation summary: it was reported that this was a posterior spinal fusion (l2) performed on (b)(6) 2023, with vbs+verse.Three months after surgery, it was installed without problems.Six months postoperatively, breakage of the screw in question and loosening of the contralateral set screw were observed.On (b)(6) 2024, the second surgery was performed to remove the screw and the set screw.The surgery was completed successfully with no surgical delay.The surgeon commented that either the screw broke and the set screw loosened due to more load on the opposite side, or the set screw loosened and the screw broke.No further information is available.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.The reported allegation cannot be confirmed.A functional evaluation was performed and met specifications with the mating device [199725650] assemble and disassemble with no problem.The overall complaint was not confirmed as the observed condition of the 5.5 exp verse unitized set scr would not contribute 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.The drawings and manufactured revisions were reviewed.Device history lot: a manufacturing record evaluation was performed for the finished device part: 199721001.Lot: l17333.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-jun-2023.Manufacturing site: jabil le locle.Expiry date:30-apr-2028.Device was used for treatment, not diagnosis.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 SARL TOLLER SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19757274
• Report Number: 1526439-2024-01840
• Device Sequence Number: 9016495
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: (01)10705034466156(17)280430(11)230609(10)L17333
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: 199721001
• Device Lot Number: L17333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: 5.5 EXP VERSE CAN SCR 6.0X50; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; VIPER2 LORDOTIC ROD-90MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown