MAUDE Adverse Event Report: DEPUY SPINE INC 5.5 EXP VERSE UNITIZED SET SCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 199721001S

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

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

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, the surgeon¿s office staff requested the metal composition for implants used on a patient.The patient was experiencing swelling, redness and irritation in his abdomen.The requested information for depuy expedium and legacy synthes - metal composition breakdowns was provided.Late the patient was referred to a dermatologist and surgeon¿s office asked if patch test kit could be provided.This report is for one (1) 5.5 exp verse unitized set scr.This is report 6 of 10 for complaint (b)(4).This complaint is related to (b)(4), and (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: b3: event year is reported as 2023, however exact date of on set of patient's swelling, redness and irritation in abdomen is unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 UNITIZED SET SCR
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 17943818
• MDR Text Key: 325768257
• Report Number: 1526439-2023-02063
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• 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: 199721001S
• 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 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.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.; 5.5 EXP VERSE UNITIZED SET SCR.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male