MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 POLYAXIAL PEDICLE SCREW

Model Number 00-1300-****

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Patient complained of pain, when additional films were taken, the rods on both sides had slid out of the proximal fixation points, but set caps were still actively engaged.

• Brand Name: 5.5/6.0 POLYAXIAL PEDICLE SCREW
• Type of Device: PEDICLE SCREW
• 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: 12139166
• MDR Text Key: 262898048
• Report Number: 3006460162-2021-00025
• 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

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-1300-****
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 70