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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE CAN SCR 6.0X45 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
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) 2020, 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 2 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.
 
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Brand Name5.5 EXP VERSE CAN SCR 6.0X45
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12786775
MDR Text Key280600343
Report Number1526439-2021-02364
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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 Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number199725645S
Device Lot Number272590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2020
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
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