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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER PRIME INSERTER CARRIER ORTHOPAEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH VIPER PRIME INSERTER CARRIER ORTHOPAEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 286750033
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/08/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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) 2020, as the surgeon was advancing the viper prime pedicle screw, the styler advanced was difficult to advance and rotate. The procedure was successfully completed with a similar product. There was no surgical delay. Concomitant device reported: viper prime pedicle screw (part# unknown, lot# unknown, quantity unknown). This report is for one (1) viper prime inserter carrier. This is report 1 of 1 for (b)(4).
 
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Brand NameVIPER PRIME INSERTER CARRIER
Type of DeviceORTHOPAEDIC STEREOTAXIC INSTRUMENT
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
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10485466
MDR Text Key206335645
Report Number1526439-2020-01594
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K170937
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 08/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286750033
Device Catalogue Number286750033
Device Lot NumberMF4344003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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