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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. MALIBU SPINAL SYSTEM POLYAXIAL SCREW DRIVER SHAFT

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SEASPINE INC. MALIBU SPINAL SYSTEM POLYAXIAL SCREW DRIVER SHAFT Back to Search Results
Model Number 91-2111
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
The remaining shaft of the instrument has not been provided for evaluation. Additionally, no radiographs have been provided for analysis. While the reported complaint cannot be confirmed or properly evaluated at this time, given the age of the device (approximately 10 years), the failure reported is consistent with normal age and wear. Review of labeling: warnings and precautions: seaspine instruments should only be used with seaspine implants. Do not attempt to use with other competitive devices. Avoid application of excessive stress on surgical instrumentation. Carefully read and follow any package insert which accompanies the implants to be used with this instrumentation. Instruments must be cleaned and decontaminated before they are returned to the manufacturer for any reason. Carefully inspect all instruments prior to use. Do not use an instrument that is severely marred or worn, or a cutting instrument with dull edges. Note that at some time, instruments may wear out and should be replaced.
 
Event Description
On (b)(6) 2020, the patient underwent spinal surgery consisting of seaspine's malibu pedicle screw system. Seaspine was informed on 30 oct 2020 that the implant screwdriver broke while implanting a screw. The driver tip was left in the screw in-situ. No injury was reported, nor any additional medical or surgical treatment.
 
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Brand NameMALIBU SPINAL SYSTEM
Type of DevicePOLYAXIAL SCREW DRIVER SHAFT
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 Key10909207
MDR Text Key243792974
Report Number3012120772-2020-00092
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K122571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number91-2111
Device Catalogue Number91-2111
Device Lot NumberMW06706B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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