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U.S. Department of Health and Human Services

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

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NUVASIVE, INC. / NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE FEMORAL LIMB LENGTHENING SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P8.5-80D245
Device Problem Defective Component (2292)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/18/2022
Event Type  Injury  
Event Description
The patient has a history of a limb length discrepancy that has been treated with a lengthening rod in the past. A lengthening rod was recently placed on (b)(6) 2022 and the rod itself was found to be malfunctioning. Options were discussed and because it had been a couple of weeks, it was decided to remove and exchange the rod and also make sure that the osteotomy was complete, so the leg would be appropriately lengthened. The defective rod was removed and replaced on (b)(6) 2022. Fda safety report id # (b)(4).
 
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Brand NamePRECICE FEMORAL LIMB LENGTHENING SYSTEM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE, INC. / NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
MDR Report Key13839961
MDR Text Key287604337
Report NumberMW5108338
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP8.5-80D245
Device Lot Number1082306AAA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/18/2022 Patient Sequence Number: 1
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