MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 199725645S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/15/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, the patient underwent a fusion (1-1(2¿4)) for a burst fracture (l3) with the expedium verse system. The surgery was completed successfully. On (b)(6) 2021 a removal surgery of expedium verse was performed for an unknown reason. During the removal surgery, the implant in l2 upper right (6 -45), l4 lower left (6 -45) broke and two screws were left in the body. Concomitant devices: unknown set screws (part# unknown, lot# unknown, qty unknown). Unknown rods (part# unknown, lot# unknown, qty unknown). Unknown screwdriver (part# unknown, lot# unknown, qty unknown). This report is for one (1) unknown expedium verse screw. This is report 1 of 2 for (b)(4).

Manufacturer Narrative

This report is for an unknown expedium verse screw/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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 CAN SCR 6.0X45
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12786740
• MDR Text Key: 280600188
• Report Number: 1526439-2021-02363
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 199725645S
• Device Lot Number: 272590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1

Treatment

UNK - LOCKING/SET SCREWS: EXPEDIUM VERSE; UNK - RODS: EXPEDIUM VERSE; UNK - SCREWS: EXPEDIUM VERSE; UNKNOWN SCREWDRIVERS