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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE SPINE LARGE SET SCREW

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ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE SPINE LARGE SET SCREW Back to Search Results
Model Number N/A
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant devices: item: 00-1003-4001, response large set screw, lot: unknown, quantity: 19; item: 00-1003-6001, response 5. 5mm rod, 500mm, lot: unknown, quantity: 2; item: 00-1300-2630, response 5. 5/6. 0 polyaxial pedicle screw 6. 0mm x 30mm, lot: unknown, quantity: 9; item: 00-1300-2635, response 5. 5/6. 0 polyaxial pedicle screw 6. 0mm x 35mm, lot: unknown, quantity: 3; item: 00-1300-2740, response 5. 5/6. 0 polyaxial pedicle screw 7. 0mm x 40mm, lot: unknown, quantity: 2; item: 00-1300-3041, response adjustable cross connector small, lot: unknown; item: 00-1300-5034, response 5. 5/6. 0 fixed cross connector, 34mm, lot: unknown; item: 00-1300-3735, response 5. 5/6. 0 polyaxial reduction pedicle screw 7, lot: unknown quantity: 2; item: 00-1300-3860, response 5. 5/6. 0 polyaxial reduction pedicle screw 8, lot: unknown; item: 00-1300-3870, response 5. 5/6. 0 polyaxial reduction pedicle screw 8, lot: unknown; item: 01-1300-3000, 1. 25mm rounded guide wire 100mm length, lot: unknown, quantity: 2. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

 
Event Description

It was reported that following the placement of the response spine system, the patient underwent a revision procedure. During the revision it was discovered that a large set screw was loose but still engaged. The construct was removed and replaced. No adverse events have been reported as a result of the malfunction.

 
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Brand NameORTHOPEDIATRICS RESPONSE SPINE LARGE SET SCREW
Type of DeviceLARGE SET SCREW
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key7579252
MDR Text Key110463519
Report Number3006460162-2018-00033
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK160466
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00-1003-4001
Device LOT NumberM-85826
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/11/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2017
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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