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

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA RADIOLUCENT HALO RING ASSY; RETRACTOR SYSTEM COMPONENTS

  • 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
 

INTEGRA LIFESCIENCES CORPORATION OH/USA RADIOLUCENT HALO RING ASSY; RETRACTOR SYSTEM COMPONENTS Back to Search Results
Catalog Number 443A1000
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
This is 1 of 3 reports for part #443a1000, linked to mfg report numbers: 3004608878-2022-00159; 3004608878-2022-00160.A facility reported that the 3 parts of the radiolucent halo ring assembly shrunk in the first sterilization cycle which made it impossible to use because they were not getting connected to each other.The incident occurred during the first surgery itself as the whole system had never been used.The medical staff had to change the entire radiolucent mayfield system to standard mayfield system and use the standard budde halo for the surgery.There was no patient injury since it was not used on the patient; however, this led to increased surgery time of 90 minutes.
 
Manufacturer Narrative
The radiolucent budde halo retractor system (a1096) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - inspection of the returned budde halo system confirms the reported complaint.The two halves of the halo ring were not able to be connected completely at the starburst teeth.The frame of the budde halo can become altered and subsequently not fit correctly following routine use and sterilization cycles.Root cause - this device is subject to wear from routine use and as a result requires routine service and preventive maintenance.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RADIOLUCENT HALO RING ASSY
Type of Device
RETRACTOR SYSTEM COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
cincinnati OH
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key15176131
MDR Text Key304977421
Report Number3004608878-2022-00158
Device Sequence Number1
Product Code GZT
Combination Product (y/n)N
PMA/PMN Number
K830332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/13/2022
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 Number443A1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/13/2022
Initial Date FDA Received08/05/2022
Supplement Dates Manufacturer Received10/10/2022
Supplement Dates FDA Received10/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-