MAUDE Adverse Event Report: FLOWER ORTHOPEDICS MFP 012; MTP PLATE, LEFT

Catalog Number MFP 012

Device Problems Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Osteolysis (2377); Patient Problem/Medical Problem (2688)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed.The original lot number of the plate was 1610300030.There were no anomalies.From the x-rays, the plate broke where there would be the highest stress.The patient displayed a malunion.The bones were not fused.The plate broke after a year of withstanding in-vivo forces.Upon review of the x-rays from a second doctor, dr.(b)(6) said: "it's too plantarflexed.The distal screw is barely biting anything and the d to p screw is too close to the joint", which created a situation where fusion would be unlikely.Therefore the root cause of the plate breakage was due to surgeon technique.A report was conducted regarding the blackness around the plate, the report determined that it was "not" "metalosis" nor infection, it was just black pigment.(b)(4).

Event Description

Mtp plate(mfp 012, lot 1701320000) implanted on (b)(6) 2018 broke; revision surgery happened on (b)(6) 2019.During the removal, there was also a report of blackness surrounding the plate, which the doctor believed could be "metalosis".

• Brand Name: MFP 012
• Type of Device: MTP PLATE, LEFT
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd.; suite 280; horsham PA 19044
• Manufacturer (Section G): MD&I; 1824 colonial village lane; lancaster PA 17601
• Manufacturer Contact: jessica huang ; 100 witmer rd.; suite 280; horsham, PA 19044 ; 9087052226
• MDR Report Key: 8271301
• MDR Text Key: 133879246
• Report Number: 3009996260-2019-00001
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840118105019
• UDI-Public: 840118105019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: MFP 012
• Device Lot Number: 1701320000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR