MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC LOCKING PROXIMAL FEMORAL PLATE, 150 DEGREE, 4.5MM, 5-HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).Device evaluated by mfr: product has not been returned to orthopediatrics for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that following the placement of a locking proximal femoral plate, the patient underwent a revision procedure due to fractured proximal screws.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow is being submitted to relay additional information.Updated: d7 updated 04 apr 2019.H4 updated 07 feb 2012.H6 updated method 10, 3331, 4109 and 4110.H6 updated results 3211.H6 updated conclusion 4315.Complaint sample was returned for evaluation.Reported event was confirmed.The dhr was reviewed and there were no process deviations that would have contributed to the failure.There were no recent design changes prior to manufacturing.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined.

• Brand Name: LOCKING PROXIMAL FEMORAL PLATE, 150 DEGREE, 4.5MM, 5-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 8601370
• Report Number: 3006460162-2019-00017
• Device Sequence Number: 1981575
• Product Code: HRS
• UDI-Device Identifier: 00841132104620
• UDI-Public: (01)00841132104620(10)M31259
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K111086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 00-0907-3205
• Device Lot Number: M31259
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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: 10 YR
• Patient Weight: 33