MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 12MM SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 202-2012

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported the patient might be diagnosed with metallosis (clinical hypothesis), and it could be related to the implanted plates and screws.No further information has been provided.Report 32 of 40 for this event.

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.Related reports: 2027754-2022-00062, 2027754-2022-00063, 2027754-2022-00064, 2027754-2022-00065, 2027754-2022-00066, 2027754-2022-00067, 2027754-2022-00068, 2027754-2022-00069, 2027754-2022-00070, 2027754-2022-00071, 2027754-2022-00072, 2027754-2022-00073, 2027754-2022-00074, 2027754-2022-00075, 2027754-2022-00076, 2027754-2022-00077, 2027754-2022-00078, 2027754-2022-00079, 2027754-2022-00080, 2027754-2022-00081, 2027754-2022-00082, 2027754-2022-00083, 2027754-2022-00084, 2027754-2022-00085, 2027754-2022-00086, 2027754-2022-00087, 2027754-2022-00088, 2027754-2022-00089, 2027754-2022-00090, 2027754-2022-00091, 2027754-2022-00092, 2027754-2022-00094, 2027754-2022-00095, 2027754-2022-00096, 2027754-2022-00097, 2027754-2022-00098, 2027754-2022-00099, 2027754-2022-00100, 2027754-2022-00101.

Manufacturer Narrative

All aspects of the investigation were reviewed.The concern was reported that "patient might be diagnosed with metallosis (clinical hypothesis) and it could be related to plates and screws implanted".Part numbers and lot numbers were reported and their respective device history records (dhrs) individually reviewed.All lots/products were manufactured according to specification.No discrepancies were found during the dhr review.Devices/products were not returned to the addison facility for further evaluation.A two-year review of complaints were performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00102, 2027754-2022-00142, 2027754-2022-00199, and their subsequent/related reports).The literature contains the proper warnings and also specifies product materials.The only known metal reported in the surgical site are the plates and screws.Possible, although improbable, sources of the debris could be the grinding of the screw head into the hole socket of the plate (over-zealous screw seating).Due to the lack of empirical evidence, or any evidence that can be objectively evaluated, this investigation cannot confirm the complaint as metallosis.No root cause of the concern can be determined at this time.

• Brand Name: 2.0MM X 12MM SCREW
• 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: 16049380
• MDR Text Key: 306151290
• Report Number: 2027754-2022-00093
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694000369
• UDI-Public: 010084569400036910116387030111
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2023

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 Model Number: 202-2012
• Device Catalogue Number: 202-2012
• Device Lot Number: 1163870
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/09/2023
• 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: Male