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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR SUNDT EXTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M; N/A
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INTEGRA NEUROSCIENCES PR SUNDT EXTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M; N/A Back to Search Results
Catalog Number NL8505076
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Event Type  malfunction  
Event Description
The user facility reported that in middle of there was a delay in surgery due to the nl8505076 sundt external with non-reinforced segment product not being delivered.A patient was prepped for surgery and there was a delay in the surgery due to the incident.The device was not in contact with a patient and there was no patient injury or death.The surgeon used a different size sundt and finished the surgery.Csr did not place order when order was sent ¿ also did not ship overnight as requested by the purchaser.
 
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Brand Name
SUNDT EXTERNAL W/NON-REINFORCED SEGMENT 3MM X 4M
Type of Device
N/A
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
Manufacturer (Section G)
INTEGRA NEUROSCIENCES PR
road 402 north, km 1.2
anasco PR 00610
Manufacturer Contact
bina patel
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6187494
MDR Text Key241268289
Report Number2648988-2016-00059
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2016
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 NumberNL8505076
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/30/2016
Initial Date FDA Received12/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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