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

Catalog Number STRM-ST5

Device Problem Failure to Osseointegrate (1863)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Device history records related to the event were reviewed.There were no non-conformances detected through the device history record review.Root cause is unknown.If additional information is obtained which changes the outcome of the investigation, a follow up report will be filed.

Event Description

Patient was implanted with a stratum straight plate- 5 hole on (b)(6) 2020.Then on (b)(6) 2020 patient underwent a revision surgery due to a non-union.Surgeon revised the case using a interfrag screw, bonus triad and a new stratum lapidus plate.No patient complications were reported.

• 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: 11021434
• MDR Text Key: 221828560
• Report Number: 3009540749-2020-00047
• 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
• Device Catalogue Number: STRM-ST5
• Device Lot Number: M1827
• 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