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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDOPATHIS SCOLIOSIS

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ORTHOPEDIATRICS, INC LARGE SET SCREW PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDOPATHIS SCOLIOSIS Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Information (3190)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant devices: item: 00-1003-4001, large set screw, lot: unknown, item: 00-1300-2850, 5. 5/6. 0 polyaxial pedicle screw 8. 0mm x 50mm, lot: 160069-g, item: 00-1300-0740, 5. 5/6. 0 uniaxial pedicle screw 7. 0mm x 40mm, lot: m849321-i, item: 00-1300-0745, 5. 5/6. 0 uniaxial pedicle screw 7. 0mm x 45mm, lot: m78684-i. 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 following a spinal fusion, the patient underwent a revision procedure due to set screw loosening. No additional patient consequences were reported.

 
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Brand NameLARGE SET SCREW
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDOPATHIS SCOLIOSIS
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 Key9498122
MDR Text Key185749362
Report Number3006460162-2019-00080
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
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 NumberM69068-B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/31/2017
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: 12/19/2019 Patient Sequence Number: 1
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