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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 PS11.5-50B235
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The exact event/explant date is unknown but reported to be in (b)(6) 2021. The device has not been returned for evaluation. The root cause is unable to be determined at this time. If any relevant additional information has been provided, a supplemental report will be submitted.
 
Event Description
Information was received that the nail separated at the junction during an explantation procedure. No patient adverse event was reported. No additional information is available.
 
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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
8583448112
MDR Report Key11785633
MDR Text Key251770120
Report Number3006179046-2021-00270
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPS11.5-50B235
Device Lot Number9012910AAA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2019
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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