MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.0MM CANNULATED CANCELLOUS SCREW, PARTIAL THREAD, T15, 50MM; ORTHOPEDIATRICS PEDILOC FRAGMENT SCREW

Model Number	N/A
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by orthopediatrics and 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 during an implantation of a pedifrag plate, a screw met a previously inserted cortical screw causing the screw to unravel in the patient.The damaged screw was removed and a new screw inserted.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to provide the following additional information: (b)(4).Complaint sample was evaluated and the report of screw unraveling was not confirmed.The screw was found to be broken at the junction of thread and neck.Investigation results concluded that the reported event was due to the screw contacting another screw during implantation.

• Brand Name: 4.0MM CANNULATED CANCELLOUS SCREW, PARTIAL THREAD, T15, 50MM
• Common Device Name: ORTHOPEDIATRICS PEDILOC FRAGMENT SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7284059
• Report Number: 3006460162-2018-00014
• Device Sequence Number: 11057116
• Product Code: HWC
• UDI-Device Identifier: 00841132113493
• UDI-Public: (01)00841132113493(10)151914-A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00-1005-4250
• Device Lot Number: 151914-A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 12/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 54