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

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.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 35MM LENGTH
• Type of Device: UNIAXIAL 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 Key: 12361358
• MDR Text Key: 271508795
• Report Number: 3006460162-2021-00034
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-1300-6635
• Device Catalogue Number: 00-1300-6635
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR