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

Model Number	202-2012
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: 2027754-2022-00199, 2027754-2022-00200, 2027754-2022-00202, 2027754-2022-00203, 2027754-2022-00204, 2027754-2022-00205, 2027754-2022-00206, 2027754-2022-00207, 2027754-2022-00208, 2027754-2022-00209, 2027754-2022-00210.
Event or Problem Description
The patient had a revision procedure on (b)(6) 2022 due to issues with the devices initially implanted on (b)(6) 2022 (previously reported in report number 2027754-2022-00142 and associated reports).After the (b)(6) 2022 revision procedure, it was reported that on (b)(6) 2022, the patient reported feeling "loose screw on the left side".It was reported a new exploration procedure was carried out, and "a new loss of the plate and bicortical screws was found".Bone material was collected, and the results are pending.The patient has not reported symptoms and imaging was performed on (b)(6) 2022 suggesting a radiolucent halo in the right side screws.The patient is currently in weekly follow-up and imaging.There is suspected metallosis.No further information has been provided.Report 3 of 12 for this event.
Additional Manufacturer Narrative
The device history records (dhrs) for the provided lot numbers were individually reviewed.All inspections of all lots passed, and no issues were identified in the dhr review.All products were manufactured and inspected according to specifications.A two-year review of complaints was performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00062, 2027754-2022-00102, 2027754-2022-00199, and their subsequent/related reports).Devices/products were not returned for further evaluation.The root cause could not be determined.

• Brand Name: 2.0MM X 12MM SCREW
• 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: 16049471
• Report Number: 2027754-2022-00201
• Device Sequence Number: 6394705
• Product Code: DZL
• UDI-Device Identifier: 00845694000369
• UDI-Public: (01)00845694000369(10)1163870(30)1(11)211101
• 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): 01/13/2023

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: 202-2012
• Device Catalogue Number: 202-2012
• Device Lot Number: 1163870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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: Female