MAUDE Adverse Event Report: OSTEOMED, LLC 90MM X 90MM RIGID OSTEOFORM MESH PLATE; SCREW, FIXATION, INTRAOSSEOUS

Model Number 218-2004

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) could not be reviewed for the part numbers associated with this complaint, as the batch/lot number is unknown.A two-year review of the complaint database identified one (1) complaint for part-number 218-2004, which is the complaint within this report.For the same timeframe, a search identified two (2) complaints for the 217-16xx part number family, one of which is related to post-op allergic reaction/hypersensitivity and is the complaint within this report.No additional complaints were identified for the reported issue of post-op allergic reaction/hypersensitivity.There were no details provided on the reported reaction and follow-up attempts did not succeed in obtaining any further information.Based on the review of risk documentation, potential causes of post-op allergic reaction are material not to specification, inadequate design, or human error (failure to determine patient allergies).However based on the limited information received and the investigation performed, the root cause could not be determined.Related report: 2027754-2023-00053.

Event Description

The patient called into the osteomed customer service department regarding osteomed part numbers 218-2004 and 217-1604.The patient reported she is having a reaction to the metal(s) in these products and requested the metal composition in these products.No further information could be obtained despite multiple follow up attempts.This is report 1 of 2 for this event.

• Brand Name: 90MM X 90MM RIGID OSTEOFORM MESH PLATE
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 18188418
• MDR Text Key: 328742717
• Report Number: 2027754-2023-00052
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 218-2004
• Device Catalogue Number: 218-2004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• 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): Other
• Patient Sex: Female