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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS LOW PROFILE CORTICAL SCREW; PLATE, FIXATION
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ZIMMER BIOMET, INC. ALPS LOW PROFILE CORTICAL SCREW; PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Information (3190)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that foreign substances were inside of the sterile packages.No adverse events have been reported as a result of the malfunction.Attempts to obtain additional information have been made; however, no more is available at this time.
 
Event Description
It was reported that foreign substances were inside of the sterile packages.No adverse events have been reported as a result of the malfunction.Attempts to obtain additional information have been made; however, no more is available at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that there is debris inside the sterile package.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to manufacturing deficiency.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
ALPS LOW PROFILE CORTICAL SCREW
Type of Device
PLATE, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7469521
MDR Text Key106852451
Report Number0001825034-2018-02989
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
PK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number851235012
Device Lot Number451970
Other Device ID Number(01)00887868055072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2018
Was the Report Sent to FDA? No
Date Manufacturer Received10/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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