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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME STYLET ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME STYLET ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 286750200S
Device Problems Break (1069); Entrapment of Device (1212); Material Twisted/Bent (2981)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 05/05/2020
Event Type  Injury  
Manufacturer Narrative

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. 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, during the surgery the stylet was broke on patient bone. The surgeon was used alternate instruments to complete the surgery. The surgery was completed successfully with 10 minutes. All generated fragments are still in l3 left pedicle. There were no patient consequences. This complaint involves two (2) device. This is report 1 of 2 for (b)(4).

 
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Brand NameVIPER PRIME STYLET
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 Key10080305
MDR Text Key193325257
Report Number1526439-2020-01070
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK171570
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number286750200S
Device Catalogue Number286750200S
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 Received07/30/2020
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: 05/21/2020 Patient Sequence Number: 1
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