MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 5MM AUTO-DRIVE SCREW; SCREW, FIXATION, BONE

Model Number	211-2005
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/04/2022
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: 2027754-2022-00142, 2027754-2022-00143, 2027754-2022-00144, 2027754-2022-00145, 2027754-2022-00146, 2027754-2022-00147, 2027754-2022-00148, 2027754-2022-00149, 2027754-2022-00150, 2027754-2022-00151, 2027754-2022-00152, 2027754-2022-00153, 2027754-2022-00154, 2027754-2022-00155, 2027754-2022-00156, 2027754-2022-00157, 2027754-2022-00158, 2027754-2022-00159, 2027754-2022-00160, 2027754-2022-00161, 2027754-2022-00162, 2027754-2022-00163, 2027754-2022-00164, 2027754-2022-00165, 2027754-2022-00166, 2027754-2022-00167, 2027754-2022-00168, 2027754-2022-00169, 2027754-2022-00170, 2027754-2022-00171, 2027754-2022-00172, 2027754-2022-00173, 2027754-2022-00174, 2027754-2022-00175, 2027754-2022-00176, 2027754-2022-00177, 2027754-2022-00178, 2027754-2022-00179, 2027754-2022-00180, 2027754-2022-00181, 2027754-2022-00182, 2027754-2022-00184, 2027754-2022-00185, 2027754-2022-00186, 2027754-2022-00187, 2027754-2022-00188, 2027754-2022-00189, 2027754-2022-00190, 2027754-2022-00191, 2027754-2022-00192, 2027754-2022-00193, 2027754-2022-00194, 2027754-2022-00195, 2027754-2022-00196, 2027754-2022-00197, 2027754-2022-00198.
Event or Problem Description
The patient was implanted on (b)(6) 2022 with no issues post-op or during clinical follow up until the patient started reporting discomfort around (b)(6) 2022 (event date) at which time imaging suggested the screw on the left side plate appeared out of the usual location.Exploratory surgery was performed on (b)(6) 2022 and found loosening of the plate and "slight movement of the distal stump".The patient was then referred to the (b)(6) for emergency removal and refixation which took place on (b)(6) 2022.The impression was that the mandibullary bone had reabsorbed around the screws and granulation tissue had formed at the site.Bacterial culture of material collected revealed it was negative.It was reported "they will be forwarding the screws removed from the patient's second surgery"- presumably, the devices explanted during the revision on (b)(6) 2022.It was also reported the patient might be diagnosed with metallosis (clinical hypothesis), and it could be related to plates and screws implanted.No further information has been provided.Report 42 of 57 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.A two-year review of complaints were performed, and zero (0) complaints for this issue (implant loosening) were noted.The literature contains the proper warnings.Devices/products were not returned for further evaluation; therefore, the root cause of the concern could not be determined.

• Brand Name: 2.0MM X 5MM AUTO-DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16049508
• Report Number: 2027754-2022-00183
• Device Sequence Number: 15039582
• Product Code: HWC
• UDI-Device Identifier: 00845694002424
• UDI-Public: (01)00845694002424(10)1164139(30)1(11)211109
• 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): 01/12/2023

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: 211-2005
• Device Catalogue Number: 211-2005
• Device Lot Number: 1164139
• 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: 01/12/2023
• 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