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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CLASSIC SCREWDRIVER PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM

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ZIMMER BIOMET SPINE INC. CLASSIC SCREWDRIVER PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number 3558-1
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event. A follow up report will be sent upon completion of the device evaluation.
 
Event Description
It was reported that a crack was found in the end of a screwdriver during an inspection. No patient was present at the time the crack was found.
 
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Brand NameCLASSIC SCREWDRIVER
Type of DevicePATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
na
westminster CO 80021
Manufacturer Contact
kim martinez
10225 westmoor dr.
na
westminster, CO 80021
3035144809
MDR Report Key15130257
MDR Text Key297257915
Report Number3012447612-2022-00182
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00889024336377
UDI-Public(01)00889024336377(10)68NR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132884
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 07/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3558-1
Device Lot Number68NR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2022
Was the Report Sent to FDA? No
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/04/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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