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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SCREWS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SCREWS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number CTL4.5-024-S
Device Problems Break (1069); Corroded (1131)
Patient Problem Failure of Implant (1924)
Event Date 11/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ. The root cause is unable to be determined at this time. If any additional information is provided, a supplemental report will be submitted.
 
Event Description
Information was received that during explant a broken screw was discovered in the right tibial construct. The broken portion of the screw remains implanted. Additionally, it was reported that there was debris/corrosion. No patient adverse event was reported.
 
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Brand NamePRECICE SCREWS
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, ste 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, ste 100
aliso viejo CA 92656
Manufacturer Contact
geoff gannon
101 enterprise dr, ste 100
aliso viejo, CA 92656
8583448112
MDR Report Key12899615
MDR Text Key282733687
Report Number3006179046-2021-00509
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193617
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTL4.5-024-S
Device Lot NumberACAGAD0525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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