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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 10/05/2018
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). Customer has indicated that the product will not be returned to orthopediatrics for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that following the placement of a response spine construct, two set screws were discovered to be disengaged. The patient was successfully revised. No additional patient consequences were reported.

 
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Brand NameORTHOPEDIATRICS RESPONSE LARGE SET SCREW
Type of DevicePEDICLE SCREW SPINAL SYSTEM
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 Key8048365
MDR Text Key126452528
Report Number3006460162-2018-00071
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 11/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1003-4001
Device LOT NumberM86486-B
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 Received10/08/2018
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

Patient TREATMENT DATA
Date Received: 11/07/2018 Patient Sequence Number: 1
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