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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAPTIVA SPINE TOWERLOX CANULATED EXT SCREW

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CAPTIVA SPINE TOWERLOX CANULATED EXT SCREW Back to Search Results
Catalog Number 16135-5545
Device Problem Osseointegration Problem (3003)
Patient Problem Insufficient Information (4580)
Event Date 03/22/2022
Event Type  Injury  
Manufacturer Narrative
When investigation and supplemental information is available in the future, a supplemental report will be provided.
 
Event Description
The physician reports progressive degenerative scoliosis patient discovered with (2) broken ext screws at upper construct lumbar level (l1) from previous instrumented fusion procedure, dated on (b)(6) 2020, clinically presenting with non-union at the l1 level.
 
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Brand NameTOWERLOX
Type of DeviceCANULATED EXT SCREW
Manufacturer (Section D)
CAPTIVA SPINE
967 n, alternate a1a
ste 1
jupiter 33477
Manufacturer (Section G)
CAPTIVA SPINE
967 n. alternate a1a
ste 1
jupiter FL 33477
Manufacturer Contact
rodney crain
967 n. alternate a1a
ste 1
jupiter, FL 33477
5612779480
MDR Report Key14178774
MDR Text Key289857930
Report Number3006082533-2022-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Catalogue Number16135-5545
Device Lot Number01190036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2022
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2022 Patient Sequence Number: 1
Treatment
TOWERLOX CANNULATED EXT SCREW
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