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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION UNK SCREW; ORTHOPAEDIC BONE SCREW

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BIOMET MICROFIXATION UNK SCREW; ORTHOPAEDIC BONE SCREW Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 09/25/2023
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10: unk plate cat#ni lot#ni, unk screw cat#ni lot#ni, unk screw cat#ni lot#ni, unk screw cat#ni lot#ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 01032347 - 2023 - 00376, 01032347 - 2023 - 00377, 01032347 - 2023 - 00379, 01032347 - 2023 - 00380.
 
Event Description
It was reported that a patient underwent a chest wall procedure at an unknown date.Subsequently, the patient experienced implant loosening no intervention has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information is available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNK SCREW
Type of Device
ORTHOPAEDIC BONE SCREW
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer (Section G)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key17912233
MDR Text Key325386006
Report Number0001032347-2023-00378
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/02/2023
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/25/2023
Initial Date FDA Received10/11/2023
Supplement Dates Manufacturer Received10/31/2023
Supplement Dates FDA Received11/02/2023
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
Treatment
SEE H10
Patient Outcome(s) Other;
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