MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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

Patient Problems Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

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.510k: this report is for an unk - screws: expedium/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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 Description

It was reported that on an unknown date the patient had a posterior lumbar spinal fusion performed on june 29th and she was experiencing pain and redness around her incision.She went in for a checkup with the doctor yesterday and they determined it was infected and she would need a debridement procedure to address the infection on july 27th.This report is for one (1)unk - screws: expedium.This is report 2 of 9 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Date of concomitant therapy is (b)(6) 2022.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 Description

It was further reported that devices belong to the expedium 5.5 spine system.

• Brand Name: UNK - SCREWS: EXPEDIUM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15274875
• MDR Text Key: 298392653
• Report Number: 1526439-2022-01433
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• 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: UNK - RODS: EXPEDIUM; UNK - RODS: EXPEDIUM; UNK - SCREWS: EXPEDIUM; UNK - SCREWS: EXPEDIUM; UNK - SCREWS: EXPEDIUM; UNK - SCREWS: EXPEDIUM; UNK - SCREWS: EXPEDIUM; UNK - SCREWS: EXPEDIUM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female