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U.S. Department of Health and Human Services

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

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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P10.7-80D275
Device Problems Break (1069); Crack (1135); Fracture (1260)
Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 03/22/2018
Event Type  Injury  
Event Description
It was reported that allegedly the patient's precise nail is damaged. The nail was revised without incident.
 
Manufacturer Narrative
No visual or functional inspections were performed as the rod was not returned. However, x-ray images revealed that the nail was observed to have a fractured crown and cracked housing tube a the crown/distraction rod junction. Additionally, the tube looks partially flared which could lead to rotation instability. It was reported that the patient weight bearing and torsional forces from patient activities my have contributed to the failure. A review of the lot history record for the device revealed that the device met all of the required quality inspections and that the products were released within specifications.
 
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Brand NamePRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise, suite 100
aliso viejo CA 92656
MDR Report Key7449670
MDR Text Key106136705
Report Number3006179046-2018-00028
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K141023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberP10.7-80D275
Device Catalogue NumberP10.7-80D275
Device Lot NumberA170612-08
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/21/2018 Patient Sequence Number: 1
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