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U.S. Department of Health and Human Services

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

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ORTHOPEDIATRICS, INC RESPONSE SET SCREW, LARGE PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

Reference: (b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted. The investigation is completed. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined.

 
Event Description

It has been reported that following the placement of a spinal construct system, a distal set screw was noted to be loose. Patient underwent revision surgery on (b)(6) 2019 to remove set screw and corresponding pedicle screw. During the revision surgery, the surgeon identified a fractured pedicle screw.

 
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Brand NameRESPONSE SET SCREW, LARGE
Type of DevicePEDICLE SCREW SPINAL SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9689063
MDR Text Key185754948
Report Number3006460162-2019-00064
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeAS
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,Followup
Report Date 07/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1003-4001
Device LOT NumberUNKNOWN
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 Received07/18/2019
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: 02/10/2020 Patient Sequence Number: 1
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