MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. STRATUM FOOT PLATING SYSTEM; PLATE

Catalog Number STRM-PNUT1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Local Reaction (2035); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

Testing of suspect devices did not reveal any evidence of corrosion in pathology report, this testing was conducted at a facility other than nextremity, and the report itself was not provided.The pathology results were reported on the addi (b)(4) provided by bsn rn (b)(6).If addtional information is provided that changes the outcome of the investigation a follow up report will be provided.

Event Description

It was reported that the patient underwent a procedure to remove arthritis and gout on the right foot on (b)(6) 2020.Tow plates were implanted.Patient underwent revision surgery due to pain with all hardware being removed.It was noted by the surgeon that it seemed as though the patient was having an adverse reaction to the implanted metal and corrosion of implant on (b)(6) 2021.

• Brand Name: STRATUM FOOT PLATING SYSTEM
• Type of Device: PLATE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer (Section G): NEXTREMITY SOLUTIONS, INC.; 1195 polk drive; warsaw IN 46582
• Manufacturer Contact: travis christman ; 1195 polk drive; warsaw, IN 46582
• MDR Report Key: 13168705
• MDR Text Key: 283249793
• Report Number: 3009540749-2021-00046
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: STRM-PNUT1
• Device Lot Number: M1320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 74 KG