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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOMED, LLC 2.0MM X 16MM SCREW; SCREW, FIXATION, INTRAOSSEOUS

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OSTEOMED, LLC 2.0MM X 16MM SCREW; SCREW, FIXATION, INTRAOSSEOUS Back to Search Results
Model Number 202-2016
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Discomfort (2330)
Event Date 10/04/2022
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: 2027754-2022-00142, 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, 2027754-2022-00192, 2027754-2022-00193, 2027754-2022-00194, 2027754-2022-00195, 2027754-2022-00196, 2027754-2022-00197, 2027754-2022-00198.
 
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) hospital for emergency removal and refixation which took place on (b)(6) 2022.The impression was that the mandibulary 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 50 of 57 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.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.
 
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Brand Name
2.0MM X 16MM 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 Key16049539
MDR Text Key306158683
Report Number2027754-2022-00191
Device Sequence Number1
Product Code DZL
UDI-Device Identifier00845694000383
UDI-Public(01)00845694000383(10)1161165(30)1(11)210803
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number202-2016
Device Catalogue Number202-2016
Device Lot Number1161165
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/15/2022
Initial Date FDA Received12/27/2022
Supplement Dates Manufacturer Received01/12/2023
Supplement Dates FDA Received01/13/2023
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 Number1
Patient Outcome(s) Other;
Patient SexFemale
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