MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM PRE-BENT PLATE, 2MM STEP, RIGHT; PLATE, BONE

Model Number 213-0049

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Discomfort (2330)

Event Date 10/04/2022

Event Type  Injury  

Event 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 56 of 57 for this event.

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, 2027754-2022-00183, 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, 2027754-2022-00198.

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: 1.6MM PRE-BENT PLATE, 2MM STEP, RIGHT
• Type of Device: PLATE, 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: 16049546
• MDR Text Key: 306159075
• Report Number: 2027754-2022-00197
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00845694003223
• UDI-Public: (01)00845694003223(10)1165840(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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 213-0049
• Device Catalogue Number: 213-0049
• Device Lot Number: 1165840
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Female