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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186715000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Additional product code kwp;kwq;mnh;mni;osh. Complainant part is not expected to be returned for manufacturer review/investigation. 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
It was reported that on (b)(6) 2020, the patient presented with issues related to a previous fusion done at (b)(6) hospital in (b)(6) on (b)(6) 2020 and all the hardware was successfully removed. The procedure was an l4-5 right sided tlif with viper prime and conduit plif cultures were taken intra-op for a suspected fungal infection. Procedure and patient outcome are unknown. This complaint involves eleven (11) devices. This report is for (1) mis single inner setscrew. This report is 7 of 10 for (b)(4).
 
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Brand NameMIS SINGLE INNER SETSCW
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)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key11049244
MDR Text Key226329302
Report Number1526439-2020-02451
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number186715000
Device Catalogue Number186715000
Device Lot Number267922
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 Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2020
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: 12/21/2020 Patient Sequence Number: 1
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