MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 8MM MMF AUTO-DRIVE SCREW; SCREW, FIXATION, INTRAOSSEOUS

Model Number 209-2008

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.Related reports: 2027754-2022-00199, 2027754-2022-00200, 2027754-2022-00201, 2027754-2022-00202, 2027754-2022-00203, 2027754-2022-00204, 2027754-2022-00206, 2027754-2022-00207, 2027754-2022-00208, 2027754-2022-00209, 2027754-2022-00210.

Event Description

The patient had a revision procedure on (b)(6) 2022 due to issues with the devices initially implanted on 20 (b)(6) 2022 (previously reported in report number 2027754-2022-00142 and associated reports).After the (b)(6) 2022 revision procedure, it was reported that on 01 december 2022, the patient reported feeling "loose screw on the left side".It was reported a new exploration procedure was carried out, and "a new loss of the plate and bicortical screws was found".Bone material was collected, and the results are pending.The patient has not reported symptoms and imaging was performed on (b)(6) 2022 suggesting a radiolucent halo in the right side screws.The patient is currently in weekly follow-up and imaging.There is suspected metallosis.No further information has been provided.Report 7 of 12 for this event.

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.All products were manufactured and inspected according to specifications.A two-year review of complaints was performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00062, 2027754-2022-00102, 2027754-2022-00199, and their subsequent/related reports).Devices/products were not returned for further evaluation.The root cause could not be determined.

• Brand Name: 2.0MM X 8MM MMF AUTO-DRIVE 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: 16049533
• MDR Text Key: 306158955
• Report Number: 2027754-2022-00205
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694001045
• UDI-Public: (01)00845694001045(10)1143660(30)1(11)191101
• 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: 01/13/2023

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: 209-2008
• Device Catalogue Number: 209-2008
• Device Lot Number: 1143660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2023
• 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