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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. A.L.P.S ANATOMIC FIBULA LOCKING PLATE PLATE, FIXATION

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ZIMMER BIOMET, INC. A.L.P.S ANATOMIC FIBULA LOCKING PLATE PLATE, FIXATION Back to Search Results
Model Number N/A
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 09/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). 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. Expected, not yet received.
 
Event Description
It was reported that during incoming inspection at the warehouse, it was discovered that a part of the sterile seal packaging is peeling off. There was no patient involvement.
 
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Brand NameA.L.P.S ANATOMIC FIBULA LOCKING PLATE
Type of DevicePLATE, 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 Key7955684
MDR Text Key123376839
Report Number0001825034-2018-09639
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK111663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number856207004
Device Lot Number885010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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