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

Device Problem Failure to Osseointegrate (1863)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

If additional information is obtained which changes the outcome of the investigation, a follow-up report will be filed.

Event Description

It was reported a revision surgery occurred on an unknown date due to a non-union involving a stratum lapidus plate.No additional information obtained.

• Brand Name: STRATUM FOOT PLATING SYSTEM
• Type of Device: PLATE
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer (Section G): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer Contact: denise holloway ; 210 north buffalo street; warsaw, IN 46580 ; 7323837901
• MDR Report Key: 11022161
• MDR Text Key: 221843710
• Report Number: 3009540749-2020-00048
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention