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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 7.0X35 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 7.0X35 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199723735S
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Additional product code kwp,kwq. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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 (b)(6) reports an event as follows: it was reported that on an unknown date of 2020, the patient underwent an unknown procedure due to implant complications. The cement was not intact. Part was left insitu - other part around screw. The procedure was successfully completed. The patient was osteopenia /osteoporotic. This complaint involves six (6) devices. Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown). Bbraun setscrews (part# unknown, lot# unknown, quantity unknown). This report is for (1) 5. 5 exp verse fen scr 7. 0x35. This report is 1 of 3 for (b)(4).
 
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Brand Name5.5 EXP VERSE FEN SCR 7.0X35
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
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10979373
MDR Text Key220974105
Report Number1526439-2020-02379
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K173095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199723735S
Device Catalogue Number199723735S
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 Received01/05/2021
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: 12/09/2020 Patient Sequence Number: 1
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