MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported that following the placement of a spinal construct, the patient was revised due to pain.It was noted that the pedicle screw placed at the left l4 pedicle was too far medial.It was revised.No additional patient consequences were reported.

• Brand Name: 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 6.0MM, 45MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 9512202
• Report Number: 3006460162-2019-00081
• Device Sequence Number: 13567900
• Product Code: OSH
• UDI-Device Identifier: 00841132100776
• UDI-Public: (01)00841132100776(10)194216-L
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-0645
• Device Lot Number: 194216-L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Weight: 67