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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation as it remains implanted.The investigation is in process.
Event or Problem Description
It has been reported that during a spinal derotation procedure, a pedicle screw fractured during derotation.The fractured portion of the screw remains in patient's bone.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREWS - 6.5MM, 40MM LENGTH
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9945765
• Report Number: 3006460162-2020-00051
• Device Sequence Number: 3358594
• Product Code: NKB
• UDI-Device Identifier: 00841132130674
• UDI-Public: (01)00841132130674(10)193831-L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-6640
• Device Lot Number: 193831-L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 60