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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION
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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION Back to Search Results
Model Number MS1-5590S
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 02/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided did not confirm the alleged event.No root cause can be confirmed at this time.
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per reporter the rods were not distracting.Reportedly, upon removing the left standard rod was pulled and it broke.As per reporter, the right rod was not saved after removal, but also appeared not to be distracting with the manual magec magnet.
 
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Brand Name
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Common Device Name
GROWING ROD SYSTEM-MAGNETIC ACTUATION
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9783257
Report Number3006179046-2020-00124
Device Sequence Number1866313
Product Code PGN
UDI-Device Identifier00812258026318
UDI-Public812258026318
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K171791
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/03/2020
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? Yes
Operator of Device Health Professional
Device Model NumberMS1-5590S
Device Lot NumberA160317-10
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/11/2020
Initial Report FDA Received Date03/03/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age6 YR
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