• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM LOCKING CAP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SEASPINE INC. MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM LOCKING CAP Back to Search Results
Model Number 12-0010
Device Problems Detachment of Device or Device Component (2907); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

The index surgery date is unknown; the revision surgery occurred approximately 3 months postoperatively. The separation was discovered during a routine follow-up via x-ray. Explants have been made available for analysis and the investigation is ongoing. The conclusion is not yet available. Possible adverse events: bending, disassembly or fracture of implant and components loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.

 
Event Description

Seaspine was informed on (b)(6) 2020 that a patient who previously underwent spinal surgery from level t2-l2 consisting of seaspine's malibu spinal system required revision surgery as a result of a postoperative locking cap separation at the t12, l1, and l2 levels.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM
Type of DeviceLOCKING CAP
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, CA 92008
7602165137
MDR Report Key11098479
MDR Text Key224523928
Report Number3012120772-2020-00093
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number12-0010
Device Catalogue Number12-0010
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/30/2020 Patient Sequence Number: 1
-
-