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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P12.5-80D305
Device Problems Collapse (1099); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information was received that the patient had finished lengthening and was in the consolidation phase when the crown cracked and the nail collapsed. No patient adverse event was reported.
 
Manufacturer Narrative
Device has not been returned for evaluation; however device return is anticipated. No conclusions can be drawn at this time. If any additional information is provided, a supplemental report will be submitted.
 
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Brand NamePRECICE SYSTEM
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 Key13545962
MDR Text Key286500303
Report Number3006179046-2022-00124
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191336
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 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP12.5-80D305
Device Lot NumberA171126-02-1AC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2017
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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