MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - RODS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Migration (4003)

Patient Problems Purulent Discharge (1812); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown rods: 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 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a removal procedure due to severe pus in the lesion.During the removal procedure the setscrew chipped.The surgeon removed two fragments from the patient¿s lesion.No more fragments were left in the patient.The procedure was completed without surgical delay.The patient received the implants on (b)(6) 2015 and the bone fusion had not been attained at the time of the removal surgery.This report involves one (1) unknown rods: expedium.This is report 2 of 5 for (b)(4).

• Brand Name: UNK - RODS: EXPEDIUM
• 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: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13543311
• MDR Text Key: 285693307
• Report Number: 1526439-2022-00224
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/16/2022
• 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: 5.5 TI CORT FIX 7X40MM.; 5.5 TI CORT FIX 7X45MM.; SINGLE-INNER SETSCREW.; VIPER TI SAI POLY 9X80MM.
• Patient Outcome(s): Required Intervention