• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. DORSAL HEIGHT ADJUSTER; SCREWDRIVER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET SPINE, INC. DORSAL HEIGHT ADJUSTER; SCREWDRIVER Back to Search Results
Catalog Number 14-501680
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported that the tip of a dorsal height adjuster fractured while removing an ha coated polaris screw intra-operatively.The procedure was completed using alternative instruments.There was no reported patient impact; however, the procedure was delayed 60 minutes.The screw was removed during a procedure to address a different level.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DORSAL HEIGHT ADJUSTER
Type of Device
SCREWDRIVER
Manufacturer (Section D)
ZIMMER BIOMET SPINE, INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer (Section G)
ZIMMER BIOMET SPINE, INC.
10225 westmoor dr.
westminster CO 80021
Manufacturer Contact
sabrina abla
10225 westmoor dr.
westminster, CO 80021
7206965158
MDR Report Key18682091
MDR Text Key335079825
Report Number3012447612-2024-00022
Device Sequence Number1
Product Code HXX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-501680
Device Lot NumberPU114B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
Patient EthnicityNon Hispanic
-
-