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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 35MM PEDICLE SCREW SPINAL SYSTEM

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ORTHOPEDIATRICS, INC 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 35MM PEDICLE SCREW SPINAL SYSTEM Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: item 00-1300-0640, 5. 5/6. 0 uniaxial pedicle screw 6mm x 40mm, lot: unknown. Customer has indicated that the product will not be returned to orthopediatrics for investigation as it is still implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that approximately one year following the placement of a response spine construct, two screws at the bottom of the construct were noted to be fractured. No adverse events have been reported as a result of the malfunction.

 
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Brand Name5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 35MM
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 Key8760796
MDR Text Key150023841
Report Number3006460162-2019-00029
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
Report Date 07/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00-1300-0635
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 Received06/03/2019
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

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