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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 130 DEG 11MM X 180MM ROD FIXATION

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ZIMMER BIOMET, INC. HFN 130 DEG 11MM X 180MM ROD FIXATION Back to Search Results
Catalog Number 814511180
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 08/10/2018
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. Product not returned.
 
Event Description
It was reported that the patient underwent a revision due to implant fracture.
 
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Brand NameHFN 130 DEG 11MM X 180MM
Type of DeviceROD FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8162081
MDR Text Key130266563
Report Number0001825034-2018-11323
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814511180
Device Lot Number5615303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
Treatment
ANTI-ROTATION SCREW CAT: 814501090, LOT: UNK; CORTICAL SCREW CAT: 814550034, LOT: UNK; LAG SCREW CAT 814510105, LOT: UNK; UNKNOWN ENDCAP
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