MAUDE Adverse Event Report: OSTEOMED, LLC 1.6MM, STRAIGHT PLATE, 18MM; PLATE, FIXATION, BONE

Model Number 213-0014

Device Problem Signal Artifact/Noise (1036)

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

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Attempts to obtain additional information regarding this event are being made.The customer was notified per the instructions for use (ifu): the devices have not been tested for safety and compatibility in the mr environment, radiofrequency (rf) heating, migration due to magnetically induced displacement, or image artifact in the mr environment, and scanning a patient who has these devices may result in patient injury.The investigation is currently pending.A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported the patient underwent a procedure on (b)(6) 2022 to remove a brain tumor and the osteomed devices were used to close the craniotomy.It was later reported by the surgeon (event date unknown) that the surgeon is unable to plan the sequential radiotherapy treatment for the patient's cancer due to the artifacts generated by the titanium plates and screws on "the mdr exam".It is currently unknown what kind of imaging was performed.It was reported the devices "were not removed from the patient yet".No adverse patient conseqiences were reported.This report is related to report numbers 2027754-2022-00039, 2027754-2022-00041, 2027754-2022-00042, 2027754-2022-00043, 2027754-2022-00044, and 2027754-2022-00045 for the other implanted devices involved in this event.

Manufacturer Narrative

Additional information received on 28 august 2022.Based on the information received, the following sections were updated: a.2; a.3; b.3; e.1; e2.; e.3; e.4; g.2.

Manufacturer Narrative

The devices were not received for evaluation.Four (4) part numbers and lot numbers were reported.All four dhrs were reviewed.Lot 1145443 (p/n 208-1605) packaged five hundred seventy-five (575) parts from bulk lot 1144717 one screw per bag on 1/20/2020.Lot 1145443 was final released to stock on 1/21/2020.All inspections passed and no issues were identified in the dhr review.The bulk lot 1144717 was machined from raw material lot 1143186, and the dhr for lot 1143186 was reviewed as well.The ti 6al-4v (mrts0006) from was purchased from the vendor and was received on 10/30/2019.All material certifications conform to astm f136-13, the standard specification for wrought titanium-6aluminum-4vanadium eli (extra low interstitial) alloy for surgical implant applications.All inspections passed and no issues were identified in the dhr review.Lot 1062827 (p/n 213-0014) manufactured and packaged (b)(4) parts released to stock on 1/7/2014.The lot was machined from raw material mrts0006 (0.23 x 5 x 8 gr-2 cp ti sheet), lot 1056955.All inspections passed and no issues were identified in the dhr review.The dhr for the titanium from lot 1056955 (mrts0006) was reviewed as well.The lot was purchased from the vendor and was received on 4/1/2013.All materials certifications conformed to astm f-67, the standard specification for unalloyed titanium, for surgical implant applications.All inspections passed and no issues were identified in the dhr review.Lot 1161156 (p/n 208-1604) packaged (b)(4) parts from bulk lot 1157552 one screw per bag on 8/4/2021.All inspections passed and no issues were identified in the dhr review.Bulk lot 1157552 was machined from the raw material lot 1157696 and the dhr for the raw material (mrtb0002) was reviewed as well.The ti 6al-4v was purchased from the vendor and was received on 4/16/2021.All material certifications conform to astm f136-13, the standard specification for wrought titanium-6aluminum-4vanadium eli (extra low interstitial) alloy for surgical implant applications.All inspections passed and no issues were identified in the dhr review.Lot 1157318 (p/n 204-1203) packaged two hundred forty (240) parts one screw per bag on 5/6/2021.The packaging lot used (b)(4) screws from lot 1149595 and (b)(4) screws from lot 1155997.All inspections passed and no issues were identified in the dhr review.Bulk lot 1149595 was machined from raw material lot 1147319 (mrtb0002) and the dhr was reviewed for the raw material as well.The lot was purchased from the vendor and was received on 4/1/2020.All material certifications conform to astm f136-13, the standard specification for wrought titanium-6aluminum-4vanadium eli (extra low interstitial) alloy for surgical implant applications.All inspections passed and no issues were identified in the dhr review.Bulk lot 1155997 was machined from the raw material lot 1154238, mrtb0002 and the dhr for the raw material was reviewed as well.All material certifications conform to astm f136-13, the standard specification for wrought titanium-6aluminum-4vanadium eli (extra low interstitial) alloy for surgical implant applications.All inspections passed and no issues were identified in the dhr review.Magnetic fields can be very fast when near metal, which may lead to dephasing and signal loss.The lack of signal may cause a black metal artifact to appear on the image.The ifus for the products used all include a section titled "mri status".This section warns that the products were not tested for safety or compatibility in the mr environment.Furthermore, the literature states that the products were not tested for image artifacts in the mr environment.

• Brand Name: 1.6MM, STRAIGHT PLATE, 18MM
• Type of Device: PLATE, FIXATION, 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: 15283248
• MDR Text Key: 298485468
• Report Number: 2027754-2022-00040
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00845694002998
• UDI-Public: (01)00845694002998(10)1062827(30)1(11)131211
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 213-0014
• Device Catalogue Number: 213-0014
• Device Lot Number: 1062827
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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: 60 YR
• Patient Sex: Male