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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA COMPRESSION BALL; N/A

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INTEGRA LIFESCIENCES CORPORATION OH/USA COMPRESSION BALL; N/A Back to Search Results
Catalog Number 443A1067
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
This is 3 of 3 reports for part #443a1067, linked to mfg report numbers: 3004608878-2022-00158, 3004608878-2022-00159.A facility reported that there was a crack in the area where the compress ball (443a1067) is placed in the radiolucent halo ring system.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
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
N/a.
 
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.There was a small crack in the threads where the compression ball is placed.Root cause - probable root cause is physical damage from rough handling of the unit.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
Manufacturer Narrative
Corrected fields: h6 (type of investigation, investigation findings, investigation conclusion).
 
Event Description
N/a.
 
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Brand Name
COMPRESSION BALL
Type of Device
N/A
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 Key15176117
MDR Text Key304996899
Report Number3004608878-2022-00160
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,Followup
Report Date 12/16/2022
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 Number443A1067
Was Device Available for Evaluation? Yes
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
12/05/2022
Supplement Dates FDA Received10/13/2022
12/16/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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