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  

Manufacturer Narrative

Post-op screw loosening was reported.The device was not returned for evaluation; however, an x-ray was provided showing loose screws in the patient's lower right jaw.Review of the device history record (dhr) and inventory review could not take place as device lot number is unknown.A two-year review of the complaint database reviewed one other complaint for this issue.That complaint was reported by the same surgeon for two different patients.Per fmea and ifu review, potential causes include improper material selection/strength, user error-improper fixation technique, and/or patient noncompliance with post-op instructions.However, based on the information received and the investigation performed, the root cause could not be determined.Related reports: 2027754-2023-00061, 2027754-2023-00062, 2027754-2023-00063, 2027754-2023-00064, 2027754-2023-00065, 2027754-2023-00066, 2027754-2023-00067, 2027754-2023-00068, 2027754-2023-00070.

Event Description

It was reported the original implant surgery occurred on (b)(6) 2023, and in (b)(6) 2023 (event date unknown), after radiographic examination, it was reported that the fixation screws on the patient's right side of the mouth were loose.It was reported the screws and plates were subsequently explanted.Report 9 of 10 for this event.

Manufacturer Narrative

Two (2) plates and eight (8) screws were received for evaluation on 19 december 2023.Visual inspection of the returned plates and screws revealed no anomalies.The product was provided to qc inspection for evaluation against the engineering drawing, and all devices met specifications.Based on the information received and the investigation performed, the root cause could not be determined.

• 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: 18263515
• MDR Text Key: 329674224
• Report Number: 2027754-2023-00069
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694001250
• UDI-Public: (01)00845694001250(10)1165829(30)1(11)20220111
• 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,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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 Manufacturer Received: 01/05/2024
• 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