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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 179762480
Device Problem No Apparent Adverse Event (3189)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Initial reporter is synthes sales representative. Without a lot number the device history records review could not be completed. Product was not returned. 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 (b)(6) 2015, an initial spinal fusion was performed for kyphosis. The procedure was for building construct in t9-s2. On (b)(6) 2015, a second procedure was performed for osteotomy in l1 and re-deploying the devices stryker¿s connector and rod which were implanted in the initial procedure. The implanted rod was connected to the stryker¿s connector. On (b)(6) 2018, the revision procedure was performed for an unknown reason. The surgeon explanted two (2) unknown expedium screws in s1 and replaced them with unknown screws. Also, one (1) screw was replaced in s2 left, s2 right. One (1) rod was explanted and replaced with two (2) rods connected to the stryker¿s connector. No further information is available. Concomitant device reported: unknown set screws (part# unknown, lot# unknown, quantity unknown), viper ti sai poly 8x70mm (part# 179704870, lot# unknown, quantity 2), unknown locking/set screws (part# unknown, lot# unknown, quantity unknown). This complaint is related to (b)(4) which involves four total procedures ((b)(6) 2015, (b)(6) 2015, (b)(6) 2018, (b)(6) 2020). This report is for one (1) expedium spine system rod 5. 5 x 480mm. This is report 3 of 5 for (b)(4).
 
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Brand NameEXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL 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 Key10174208
MDR Text Key196424324
Report Number1526439-2020-01214
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111136
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
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number179762480
Device Catalogue Number179762480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/19/2020 Patient Sequence Number: 1
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