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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 Insufficient Information (4580)
Event Date 12/07/2022
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: 2027754-2022-00102, 2027754-2022-00103, 2027754-2022-00104, 2027754-2022-00105, 2027754-2022-00106, 2027754-2022-00107, 2027754-2022-00108, 2027754-2022-00109, 2027754-2022-00110, 2027754-2022-00111, 2027754-2022-00112, 2027754-2022-00113, 2027754-2022-00114, 2027754-2022-00115, 2027754-2022-00116, 2027754-2022-00117, 2027754-2022-00118, 2027754-2022-00119, 2027754-2022-00120, 2027754-2022-00121, 2027754-2022-00122, 2027754-2022-00123, 2027754-2022-00124, 2027754-2022-00125, 2027754-2022-00126, 2027754-2022-00127, 2027754-2022-00128, 2027754-2022-00129, 2027754-2022-00130, 2027754-2022-00131, 2027754-2022-00132, 2027754-2022-00133, 2027754-2022-00134, 2027754-2022-00135, 2027754-2022-00136, 2027754-2022-00138, 2027754-2022-00139, 2027754-2022-00140, 2027754-2022-00141.
 
Event Description
It was reported the patient might be diagnosed with metallosis (clinical hypothesis), and it could be related to the implanted plates and screws.No further information has been provided.Report 36 of 40 for this event.
 
Manufacturer Narrative
All aspects of the investigation were reviewed.The concern was reported that "patient might be diagnosed with metallosis (clinical hypothesis) and it could be related to plates and screws implanted".Part numbers and lot numbers were reported and their respective device history records (dhrs) individually reviewed.All lots/products were manufactured according to specification.No discrepancies were found during the dhr review.Devices/products were not returned to the addison facility for further evaluation.A two-year review of complaints were performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00102, 2027754-2022-00142, 2027754-2022-00199, and their subsequent/related reports).The literature contains the proper warnings and also specifies product materials.The only known metal reported in the surgical site are the plates and screws.Possible, although improbable, sources of the debris could be the grinding of the screw head into the hole socket of the plate (over-zealous screw seating).Due to the lack of empirical evidence, or any evidence that can be objectively evaluated, this investigation cannot confirm the complaint as metallosis.No root cause of the concern can be determined at this time.
 
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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 Key16049385
MDR Text Key306157810
Report Number2027754-2022-00137
Device Sequence Number1
Product Code DZL
UDI-Device Identifier00845694000383
UDI-Public010084569400038310116116530111
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 01/08/2023
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 12/08/2022
Initial Date FDA Received12/27/2022
Supplement Dates Manufacturer Received01/06/2023
Supplement Dates FDA Received01/09/2023
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 SexMale
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