MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by orthopediatrics and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that during the placement of a uniaxial pedicle screw, the screw head disassembled from the shaft of the screw.The screw was removed and a new screw implanted.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9714167
• MDR Text Key: 190692958
• Report Number: 3006460162-2020-00007
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 0084113210045
• UDI-Public: (01)0084113210045(10)200269-L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-0735
• Device Lot Number: 200269-L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 47