MAUDE Adverse Event Report: OSTEOMED, LLC; SCREW, FIXATION, INTRAOSSEOUS

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

In the article " a ramus cortical bone harvesting technique without bone marrow invasion." by ku, j., ghim, m., park, j.H., and leem, d.H., detailed a harvesting technique.Per the authors, one patient (50 year old male) received two dental implants with a complication-free harvesting technique that involved creation of ditching holes with a 1 mm round bur.Patient had a history of controlled hypertension.Patient visited the clinic with loss of the right maxillary premolars (#14 and #15).Radiography revealed severe bone defects in the patient's right maxilla.Reconstructive surgery with delayed implant placement was recommended using autogenous bone graft.Sagittal, coronal, and axial osteotomies produced grid-type cortical squares using a micro-saw and a round bur to confirm the cortical thickness.The grid-type cortical bone was harvested from the occlusal aspect, and the harvesting was extended through an additional osteotomy on the exposed and remaining cortical bone to prevent bone marrow invasion.The harvested grid-shape cortical bone was crushed by bone mill or crusher to easily manipulate and increase the contact area at the recipient site.To create a proper shape for implant placement, the grafts were fixed using titanium mesh (made by a different manufacturer) with two micro-screws (diameter 1.5 mm, 6 mm length; osteomed), and primary closure was completed after creating a releasing incision of the flap.The patient did not suffer postoperative severe pain, swelling, or numbness.After 15 months, the harvested site exhibited new cortical bone lining, and the grafted area had healed to a cortico-cancellous complex with functional loading of the implants.As osteomed screws were used with mesh from a different manufacturer, this is off-label use.This is report 1 of 2 for the two screws involved in this event.

Manufacturer Narrative

The complaint was documented as a result of review of scientific literature article due to off-label use.Device information (model number and batch/lot number) is unknown.Therefore, review of the device history record could not be performed.The device was not received for evaluation.Additionally, as the device information was unknown, a two-year review of the complaint database could not be performed based on part number; however, a review was still performed based on the reported event of off-label use yielding only one complaint (the complaint within this report).As the article identified a 1.5mm x 6 mm "micro screw", this screw would be included in one of the craniomaxillofacial (cmf) systems.Therefore, corresponding instructions for use (ifus) were reviewed.The clinical indications is clearly detailed within its own section for each ifu.Additionally, within the "maintaining device effectiveness" section, the following is stated: "all osteomed plates, screws, and instrumentation may be required for each surgery.Failure to use dedicated, unique osteomed instruments for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury.Failed devices may require re-operation and removal." or "dedicated osteomed plates, screws, and instrumentation are required for each surgery.Failure to use dedicated, unique osteomed instruments for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury.Failed devices may require re-operation and removal." based on the information received and the investigation performed, the root cause of the reported event could not be conclusively determined.This report is related to report number 2027754-2023-00014 which is for the other screw described in this article.

• 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: 16896055
• MDR Text Key: 314837737
• Report Number: 2027754-2023-00013
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2023
• 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 Age: 50 YR
• Patient Sex: Male