MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE LARGE SET SCREW; PEDICLE SCREW SPINAL SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that following a posterior fusion surgery, the patient experienced back pain and clicking.It was discovered during the revision procedure that a set screw was loose.No additional patient consequences were reported.

• Brand Name: RESPONSE LARGE SET SCREW
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 8571189
• Report Number: 3006460162-2019-00015
• Device Sequence Number: 16603281
• Product Code: OSH
• UDI-Device Identifier: 00841132100103
• UDI-Public: (01)00841132100103(10)M69067-B
• 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: 2018
• 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): 05/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1003-4001
• Device Lot Number: M69067-B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 05/01/2019
• 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: 17 YR