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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 2.7 LOCKING SCREW; SCREW, FIXATION
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ZIMMER BIOMET, INC. UNKNOWN 2.7 LOCKING SCREW; SCREW, FIXATION Back to Search Results
Catalog Number UNKNOWN
Device Problem Corroded (1131)
Patient Problem No Information (3190)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: (b)(6).Product not returned.
 
Event Description
It was reported that the products were removed due to implant corrosion.Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
UNKNOWN 2.7 LOCKING SCREW
Type of Device
SCREW, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8961822
MDR Text Key156558428
Report Number0001822565-2019-03806
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN 2.7 MM LOCKING SCREW; UNKNOWN 2.7 MM LOCKING SCREW; UNKNOWN 2.7 MM LOCKING SCREW; UNKNOWN 2.7 MM LOCKING SCREW; UNKNOWN 3.5 MM LOCKING SCREW; UNKNOWN 3.5 MM LOCKING SCREW; UNKNOWN 3.5 MM LOCKING SCREW; UNKNOWN 3.5 MM NON-LOCKING SCREW; UNKNOWN 3.5 MM NON-LOCKING SCREW; UNKNOWN FIBULAR PLATE
Patient Outcome(s) Hospitalization; Required Intervention;
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