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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179702000
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. (b)(4). 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 set screw from the right l4 screw ¿popped-off¿ during an unknown procedure. Revision surgery was required. The surgeon removed the remaining two set screws at l5/s1, rod, and l4 screw. No further information was provided. Concomitant device reported: unknown screws (part# unknown, lot# unknown, quantity unknown ). Unknown rods (part# unknown, lot# unknown, quantity unknown ). This report is for one (1) expedium spine system single inner set screw 5. 5. This is report 1 of 5 for (b)(4).
 
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Brand NameEXPEDIUM SPINE SYSTEM SINGLE INNER SET SCREW 5.5
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10869180
MDR Text Key217151738
Report Number1526439-2020-02242
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034064307
UDI-Public(01)10705034064307
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179702000
Device Catalogue Number179702000
Device Lot Number261035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
Treatment
MMSI ROD PREBENT, 5.5 X75MM, T; SI POLYAXL SCREW 6 X 45MM; UNK LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS
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