MAUDE Adverse Event Report: OSTEOMED, LLC 2.4MM X 8MM SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 206-2408

Device Problem Off-Label Use (1494)

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

Event Date 06/06/2023

Event Type  Injury  

Event Description

It was reported during the surgery, the surgeon noted that the osteomed screw was too large to fit into the pilot drill hole.The surgeon noted that the screw was larger and reported this to the sales representative of another manufacturer.This sales representative noted the osteomed screw was larger when comparing it to other osteomed screws that were sent in the kit.This procedure was completed with additional screws that had been provided of the same type.There were no adverse patient consequences reported, and the surgery was not prolonged.During the course of follow up, it was determined that these osteomed screws were provided in their packaging to another manufacturer who then is loading these screws into a kit containing that manufacturer's implant.These screws are being used with that manufacturer's tmj prothesis/implant.This is off-label use.

Manufacturer Narrative

The investigation is currently pending.A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional information was received which provided the sex of the patient and the batch/lot number of the reported device.Therefore, b3 and d4 were updated.Initially it had been reported the device was available for evaluation; however, it was later determined the device had been discarded and was not available for return.Therefore, d9 was updated.The device history report (dhr) was reviewed for the lot number provided.The dhr confirmed no discrepancies were identified and all parts were manufactured and inspected according to specification.Parts were packaged using the automated packaging machine.No discrepancies were found in the line clearance form.An image was provided by the customer of the screw being measured with a caliper.Based solely on the image provided by the customer , it appears the screw major diameter measured 2.6 mm, or 0.102 in.The drawing of the screw was reviewed.Based on the measurement in the image provided by the complainant, the screw did not meet the diameter specifications.A review of all safety screw drawings found that the major diameter of 0.102 inches corresponds the 206-27xx drawing.It is possible screw identified by the customer was a 206-2708 screw that was packaged as a 206-2408 screw.However, without the device, this could not be conclusively determined.During follow up regarding complaint details, it was determined that these osteomed screws were provided in their packaging to another manufacturer who then is loading these screws into a kit containing that manufacturer's implant.These screws are being used with that manufacturer's tmj prothesis/implant.Based on the information received and the investigation performed, it was determined the screws were being used off-label.

• Brand Name: 2.4MM X 8MM SCREW
• 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: 17309783
• MDR Text Key: 318921203
• Report Number: 2027754-2023-00027
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694000758
• UDI-Public: (01)00845694000758(10)1172762(30)1(11)220818
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 206-2408
• Device Catalogue Number: 206-2408
• Device Lot Number: 1172762
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2023
• 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