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

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 11/23/2019

Event Type  Injury  

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 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
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; wasaw, IN 46582 ; 5742670872
• MDR Report Key: 9512202
• MDR Text Key: 185749693
• Report Number: 3006460162-2019-00081
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 00841132100776
• UDI-Public: (01)00841132100776(10)194216-L
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-0645
• Device Lot Number: 194216-L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 67