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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 PS10.0-50SJ235
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
The device was not made available for evaluation.The root cause is unable to be determined.If any additional information is provided, a supplemental report will be submitted.Journal article citation: frommer, adrien, et al."focal osteolysis and corrosion at the junction of precice stryde intramedullary lengthening device." bone and joint research, vol.10, no.7, 16 july 2021.
 
Event Description
Information was received that the patient experienced lytic osteolysis.
 
Event Description
N/a.
 
Manufacturer Narrative
Additional data.
 
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Brand Name
PRECICE STRYDE SYSTEM
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise dr, suite 100
aliso viejo CA 92656
MDR Report Key12291322
MDR Text Key265552489
Report Number3006179046-2021-00437
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K180503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPS10.0-50SJ235
Device Lot Number9103001AAA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received08/23/2021
Supplement Dates FDA Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age19 YR
Patient Weight54
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