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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Product has been received by orthopediatrics and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It has been reported that during the placement of a uniaxial pedicle screw, the screw head disassembled from the shaft of the screw. The screw was removed and a new screw implanted. No adverse events have been reported as a result of the malfunction.

 
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Brand NameRESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9714167
MDR Text Key190692958
Report Number3006460162-2020-00007
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 01/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-0735
Device LOT Number200269-L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/19/2019
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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