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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE BONE TRANSPORT SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE BONE TRANSPORT SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number BT115-10SJ360-7
Device Problem Separation Failure (2547)
Patient Problem Failure of Implant (1924)
Event Date 05/28/2020
Event Type  malfunction  
Manufacturer Narrative
No product has been returned for evaluation nor were radiographs provided to confirm the alleged event.
 
Event Description
Information was received during a nail removal on (b)(6) 2020, the distal end of the nail pulled apart due to the retention plug not being utilized.As per the reporter, all the pieces of the nail were retrieved.
 
Manufacturer Narrative
Additional information provided in d4 (lot number).The device history records were reviewed and no capa or change order have been issued for this complaint.
 
Event Description
Additional information provided in d4.
 
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Brand Name
PRECICE BONE TRANSPORT SYSTEM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key10311979
MDR Text Key199993907
Report Number3006179046-2020-00349
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00887517979063
UDI-Public887517979063
Combination Product (y/n)N
PMA/PMN Number
K182170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBT115-10SJ360-7
Device Lot Number0041702AAA
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight68
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