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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL LINESIDER NON-MOD STANDARD TULIP, DUAL LEAD SHANK THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL LINESIDER NON-MOD STANDARD TULIP, DUAL LEAD SHANK THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number LS-N6SA7550
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  Injury  
Manufacturer Narrative
This complaint lot has been recalled for a separate issue under manufacturer recall number 3012797630-02022022-00006-r.
 
Event Description
On 03feb22 accelus was informed of a complaint on a linesider non-modular standard screw. It was originally reported by the rep that an intraoperative screw head separation had occurred during the procedure. At the time, this was all the information that was available. New information was received on 11mar22. Per the complaint entry form received on 11mar22, the reported weld failure occurred during a revision procedure. The initial surgery was a 4 level plif and fixation procedure that took place on (b)(6) 2021. During a postoperative follow up visit it was noted that one of cephalad screws was loosening, as a result, the surgeon opted to revise the procedure. The revision procedure took place on (b)(6) 2022. It was noted during the revision procedure that one of the caudal screws had a separated tulip head. It is unknown if this separation occurred postoperatively or during the revision procedure. The procedure was completed by removing and replacing the loose cephalad screw and the separated caudal screw. The reported weld failure resulted in a 10 minute delay to the revision procedure. No additional patient harm was reported as a result of this occurrence.
 
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Brand NameLINESIDER NON-MOD STANDARD TULIP, DUAL LEAD SHANK
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL
integrity implants inc
354 hiatt drive
palm beach gardens FL 33418
Manufacturer (Section G)
INTEGRITY IMPLANTS INC
354 hiatt drive
palm beach gardens FL 33418
Manufacturer Contact
rod atkins
354 hiatt drive
palm beach gardens, FL 33418
5615064996
MDR Report Key14074144
MDR Text Key289002862
Report Number3012797630-2022-00013
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00818613027891
UDI-Public(01)00818613027891(10)02210131
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLS-N6SA7550
Device Catalogue NumberLS-N6SA7550
Device Lot Number02210131
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/20/2020
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: 04/11/2022 Patient Sequence Number: 1
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