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

Model Number	211-2005
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-op plate breakage was reported.No additional information was received.The device was not returned for evaluation; however, an x-ray was provided showing a broken plate on the patient's lower right jaw.Review of the dhr and inventory review could not take place as device lot number is unknown.As the part number is unknown, a two-year review of the complaint database for all craniomaxillofacial plates revealed only one (1) complaint for post-op plate breakage- which is the complaint within this report.Per fmea and ifu review, potential causes for post-op plate breakage include improper material selection/strength, user error-improper fixation technique, patient noncompliance with post-op instructions, excessive bending while contouring plates, improper plate size selection, and no/slow osteogenesis, osteolysis, bone resorption.However, based on the information received and the investigation performed, the root cause could not be determined.
Event or Problem Description
It was reported an implanted plate broke post-operatively.No further information regarding event date, device information, and patient status could be obtained despite multiple follow up attempts.
Additional Manufacturer Narrative
Additional information was received on 22 december 2023 regarding the patient and the reported event.It was reported the original implant surgery was on (b)(6) 2023, and 12 days after surgery (event date on 17 october 2023), a radiographic examination was performed where it was confirmed that the fixed plates were broken.On (b)(6) 2023, a new surgery was performed, where the material was explanted, and a new material was implanted again.The devices were received on 19 december 2023 for evaluation.Review of the dhrs revealed no anomalies.Additionally, review of material composition of the devices as well as manufacturing processes indicated no changes to either since release of these products.As received, the four (4) plates were fractured, and visual inspection revealed some warping on the plates.It is unknown if this warping occurred due to the reported event, during the initial implant surgery, or due to explant damage.Visual inspection of the returned screws revealed no anomalies.The returned parts were given to qc inspection for evaluation against the engineering drawings, and all devices met specifications.A two-year review of the complaint database for the 211-20xx part family revealed only one (1) complaint for post-op plate breakage- which is the complaint within this report.Similarly, review of the complaint database for part number 210-0030 revealed one (1) complaint for post-op plate breakage (which is the complaint in this report).Potential causes for post-op plate breakage include improper material selection/strength, user error-improper fixation technique, patient noncompliance with post-op instructions, excessive bending while contouring plates, improper plate size selection, and no/slow osteogenesis, osteolysis, bone resorption.However, based on the information received and the investigation performed, the root cause could not be determined.Based on the additional information received on 22 december 2023, it was reported additional devices were involved, therefore, the following related reports have been submitted: 2027754-2024-00002, 2027754-2024-00003, 2027754-2024-00004, 2027754-2024-00005, 2027754-2024-00006, 2027754-2024-00007, 2027754-2024-00008, 2027754-2024-00009, 2027754-2024-00010, 2027754-2024-00011, 2027754-2024-00012, 2027754-2024-00013, 2027754-2024-00014, 2027754-2024-00015, 2027754-2024-00016, 2027754-2024-00017, 2027754-2024-00018, 2027754-2024-00019, and 2027754-2024-00020.

• Brand Name: 2.0MM X 5MM AUTODRIVE 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: 18242848
• Report Number: 2027754-2023-00054
• Device Sequence Number: 20523895
• Product Code: HWC
• UDI-Device Identifier: 00845694002424
• UDI-Public: (01)00845694002424(10)1177635(30)1(11)230313
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 1177635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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