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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number PS10.0-50SJ235
Device Problem Corroded (1131)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
The device was not made available for evaluation. The root cause is unable to be determined. If any additional information is provided, a supplemental report will be submitted. Journal article citation: frommer, adrien, et al. "focal osteolysis and corrosion at the junction of precice stryde intramedullary lengthening device. " bone and joint research, vol. 10, no. 7, 16 july 2021.
 
Event Description
Information was received that the patient reported pain during distraction and consolidation. Additionally, the nail was found to have a corrosive stain.
 
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Brand NamePRECICE STRYDE SYSTEM
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
geoff gannon
101 enterprise dr, suite 100
aliso viejo, CA 92656
MDR Report Key12290009
MDR Text Key265492882
Report Number3006179046-2021-00430
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS10.0-50SJ235
Device Lot Number8111266AAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2018
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: 08/06/2021 Patient Sequence Number: 1
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