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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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ORTHOPEDIATRICS, INC UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device is not available for evaluation as it remains implanted. The investigation is currently underway.

 
Event Description

It has been reported that following a spinal correction procedure, the patient was found via radiograph, to have a fractured pedicle screw. A revision surgery has been scheduled. No additional patient consequences have been reported.

 
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Brand NameUNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw, in
Manufacturer Contact
kriss anderson
2850 frontier drive
warsaw, in 
2670872
MDR Report Key9891647
MDR Text Key190837170
Report Number3006460162-2020-00050
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,Followup
Report Date 03/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
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 Received02/28/2020
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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