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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC JANUS FENESTRATED SCREWS TALL ADAPTER

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ORTHOFIX MEDICAL INC JANUS FENESTRATED SCREWS TALL ADAPTER Back to Search Results
Model Number 36-1605
Device Problems Positioning Failure (1158); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
Information provided states that during a case on (b)(6) 2020, the cement leaked out of the tall adapter and into the tulip head of the open body assembly. The surgeon was unable to seat the rod correctly. A revision surgery was performed on (b)(6) 2020 to remove the open body assembly and re-seat the rod.
 
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Brand NameJANUS FENESTRATED SCREWS
Type of DeviceTALL ADAPTER
Manufacturer (Section D)
ORTHOFIX MEDICAL INC
3451 plano parkway
lewisville TX 75056
Manufacturer (Section G)
ORTHOFIX MEDICAL INC
3451 plano parkway
lewisville TX 75056
Manufacturer Contact
yolanda thompson
3451 plano parkway
lewisville, TX 75056
2149372291
MDR Report Key10800728
MDR Text Key239407517
Report Number2183449-2020-00008
Device Sequence Number1
Product Code NKB
UDI-Device Identifier18257200133543
UDI-Public18257200133543
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number36-1605
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2020
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? No
Type of Device Usage Initial

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