MAUDE Adverse Event Report: OSTEOMED, LLC 24MM 4 HOLE STRAIGHT PLATE; SCREW, FIXATION, INTRAOSSEOUS

Model Number 210-0030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

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 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.

Manufacturer Narrative

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.Original report was submitted: report number 2027754-2023-00054.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, and 2027754-2024-00020.

• Brand Name: 24MM 4 HOLE STRAIGHT PLATE
• 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: 18466302
• MDR Text Key: 332381930
• Report Number: 2027754-2024-00019
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694001250
• UDI-Public: (01)00845694001250(10)1165829(30)1(11)220111
• 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
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 210-0030
• Device Catalogue Number: 210-0030
• Device Lot Number: 1165829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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