MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 7.0X50; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	199723750S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 an unknown surgery performed on (b)(6) 2024, with the cement in question.This surgery was the second surgery, and there were no j&j products used in the initial surgery.Two and a half (2.5) months after the surgery, the screw loosening was confirmed.A large clear zone had formed around the cement mass.This is a case where the cement is not firmly engaged and in which the screw may be removed with cement lumps stuck around it.No additional information is available.Remarks: (b)(4) and (b)(4) are involved with the same event.(b)(4) (synthes spine): cement (b)(4) (depuy spine): screw this report is for one (1) 5.5 exp verse fen scr 7.0x50 this is report 1 of 1 for complaint (b)(4).
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.Additional narrative: e1.H6 component code: g07002 ¿ device not returned.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 FEN SCR 7.0X50
• 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
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19209869
• Report Number: 1526439-2024-01408
• Device Sequence Number: 12744394
• Product Code: NKB
• UDI-Device Identifier: 10705034444499
• UDI-Public: (01)10705034444499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 199723750S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown