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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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ORTHOPEDIATRICS, INC 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number N/A
Device Problem Use of Device Problem (1670)
Patient Problem Pain (1994)
Event Date 11/23/2019
Event Type  Injury  
Manufacturer Narrative

(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 has been reported that following the placement of a spinal construct, the patient was revised due to pain. It was noted that the pedicle screw placed at the left l4 pedicle was too far medial. It was revised. No additional patient consequences were reported.

 
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Brand Name5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC 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
wasaw, IN 46582
5742670872
MDR Report Key9512202
MDR Text Key185749693
Report Number3006460162-2019-00081
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
Report Date 12/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-0645
Device LOT Number194216-L
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 Received11/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2019
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: 12/23/2019 Patient Sequence Number: 1
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