MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 40MM LENGTH

Model Number 00-1300-6640

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

A t11-l3 fusion was performed (b)(6) 2019.Patient presented with painful lower back and after xrays and ct was discovered that one.L3 screw had broken and the other l3 screw was loose.A revision surgery was performed.The broken and loose l3 screws were removed and replaced with larger diameter screws.L4 was also instrumented and the fusion was extended.

• Brand Name: 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 40MM 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: 12084599
• MDR Text Key: 261688714
• Report Number: 3006460162-2021-00021
• 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: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-1300-6640
• Device Catalogue Number: 00-1300-6640
• Device Lot Number: 189590-L
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1