MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 4.5MM LOCKING SCREW, 70MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 distal femoral osteotomy procedure, an implanted screw was found to be fractured.Patient underwent a revision procedure.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 4.5MM LOCKING SCREW, 70MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsarw IN 46582
• MDR Report Key: 8659826
• Report Number: 3006460162-2019-00020
• Device Sequence Number: 2566995
• Product Code: HWC
• UDI-Device Identifier: 00841132111949
• UDI-Public: (01)00841132111949(10)181098-G
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2019

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: 00-0907-4670
• Device Lot Number: 18098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/31/2019
• 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 Weight: 132