MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X55; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 199723655S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that sales rep was contacted by surgeon¿s office staff on (b)(6) /2023 requesting the metal composition for implants used on a patient.He emailed surgeon and his staff directly after being contacted.He provided them with the requested information for expedium and metal composition breakdowns.They said the patient was experiencing swelling, redness and irritation in his abdomen.Potentially may be having a reaction to the implants.He was contacted again by surgeon¿s office this afternoon.The patient was referred to a dermatologist and surgeon¿s office asked if we could provide "patch test kit¿.This report is for one (1) 5.5 exp verse fen scr 6.0x55 this is report 4 of 10 for complaint (b)(4).

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.H10 additional narrative: d2b: additional product codes: kwp and kwq.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X55
• Type of Device: 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: 17939966
• MDR Text Key: 325739606
• Report Number: 1526439-2023-02035
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443546
• UDI-Public: (01)10705034443546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 199723655S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 7.0X50; 5.5 EXP VERSE FEN SCR 7.0X50; 5.5 EXP VERSE FEN SCR 8.0X80; 5.5 EXP VERSE FEN SCR 8.0X80
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male