MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 4.5MM 90 DFOS PLATE, 5 FLARE, NO OFFSET, 4 HOLE; PEDILOC, PLEO PEDILOC FEMUR

Model Number	00-1050-6004
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).Concomitant medical products: unknown locking screw: item number; unknown, lot number; unknown qty of four (4).Customer has indicated that the product will be returned to orthopediatrics for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2020-00032, 3006460162-2020-00033, 3006460162-2020-00034 and 3006460162-2020-00035.
Event or Problem Description
It was reported that the dfos plate failed and the screws broke.The patient was revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 patient code: 1924, h6 device code: 1260, h6 method code: 3331 - 4109, h6 result code: 3252, h6 conclusion code: 4315, d10 device available for evaluation: yes.Complaint sample was evaluated and the reported event was confirmed.Product evaluation confirmed broken screws.The plate was found to be undamaged.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.

• Brand Name: 4.5MM 90 DFOS PLATE, 5 FLARE, NO OFFSET, 4 HOLE
• Common Device Name: PEDILOC, PLEO PEDILOC FEMUR
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9717271
• Report Number: 3006460162-2020-00031
• Device Sequence Number: 11351141
• Product Code: HRS
• UDI-Device Identifier: 00841132129975
• UDI-Public: (01)00841132129975(10)162982-C
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 00-1050-6004
• Device Catalogue Number: 00-1050-6004
• Device Lot Number: 162982-C
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 07/16/2020
• 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