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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
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NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM; FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY Back to Search Results
Model Number DBB5-000
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/17/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Even though root cause cannot be confirmed, reporter believes either the drill bushings/guide tubes are bent or the guide arm is damaged.With no product or pictures event cannot be confirmed.
 
Event or Problem Description
As per the reporter during the implant procedure the drill wouldn't pass through the guide and then through the nail causing a delay in therapy.No patient harm reported.
 
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Brand Name
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
Common Device Name
FIXATION DEVICE, INTERNAL, NAIL, INTRAMEDULLARY
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9965750
Report Number3006179046-2020-00269
Device Sequence Number3676302
Product Code HSB
UDI-Device Identifier00812258022037
UDI-Public812258022037
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K173129
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberDBB5-000
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/18/2020
Initial Report FDA Received Date04/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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