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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 CTL4.5-022-S
Device Problem Break (1069)
Patient Problem Deformity/ Disfigurement (2360)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
A review of the device history record for the screw confirmed no deviations in the manufacturing process and that the finished product met all required quality inspections prior to release. A supplemental report will be submitted with device evaluation findings.
 
Event Description
It was reported that in the early lengthening phase, it was discovered that the patient's tibia was developing a slight procurvatum deformity; however it was decided to continue with the lengthening process. During removal of the plate after lengthening had reached an acceptable result, one of the 4. 5mm locking screws in the distal segment of the plate was noted to be broken and it was also discovered that the screw had been implanted with purchase in the near cortex only. Additionally, it was reported the plate had been implanted in an inverted orientation. The surgeon made alignment adjustments and reinforced the surgical site with a static locking plate. Report 1 of 2.
 
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Brand NamePRECICE SCREWS
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer (Section G)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
Manufacturer Contact
tiara rae
101 enterprise dr, suite 100
aliso viejo, CA 92656
6197314188
MDR Report Key11589047
MDR Text Key242932261
Report Number3006179046-2021-00210
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTL4.5-022-S
Device Lot NumberACAAAE0425
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2021 Patient Sequence Number: 1
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