MAUDE Adverse Event Report: OSTEOMED, LLC MEDIUM 4 HOLE BSSO PLATE; SCREW, FIXATION, INTRAOSSEOUS

Model Number	214-0080
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.Related reports: 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, 2027754-2022-00093, 2027754-2022-00094, 2027754-2022-00095, 2027754-2022-00096, 2027754-2022-00097, 2027754-2022-00098, 2027754-2022-00099, 2027754-2022-00100, 2027754-2022-00101.
Event or Problem 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.
Additional 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: MEDIUM 4 HOLE BSSO PLATE
• Common Device Name: 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: 16049293
• Report Number: 2027754-2022-00062
• Device Sequence Number: 17753045
• Product Code: DZL
• UDI-Device Identifier: 00845694003599
• UDI-Public: 010084569400359910116700430111220
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 214-0080
• Device Catalogue Number: 214-0080
• Device Lot Number: 1167004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male