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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 35MM LENGTH

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ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 35MM LENGTH Back to Search Results
Model Number 00-1300-6635
Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)
Patient Problem Pain (1994)
Event Type  malfunction  
Event Description
The set screw at l3 on the left loosened causing screw to move in the pedicle and the veritable body to wedge causing the patient pain at that level.
 
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Brand Name5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 35MM LENGTH
Type of DeviceUNIAXIAL PEDICLE SCREWS
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
james gunnels
2850 frontier drive
warsaw, IN 46582
MDR Report Key12361358
MDR Text Key271508795
Report Number3006460162-2021-00034
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00-1300-6635
Device Catalogue Number00-1300-6635
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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