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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM TI PEDICLE SCREW SYSTEM VERSION OR MODEL: 39-SG-6540; MODULAR BONE SCREW
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PRECISION SPINE, INC. REFORM TI PEDICLE SCREW SYSTEM VERSION OR MODEL: 39-SG-6540; MODULAR BONE SCREW Back to Search Results
Model Number 39-SG-6540
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 05/21/2021
Event Type  Injury  
Manufacturer Narrative
Patient information - unknown.Occupation - other; sales representative.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
 
Event Description
It was reported that a procedure was performed on (b)(6) 2021, utilizing the reform ti modular pedicle screw system.Subsequently, the patient underwent revision surgery on (b)(6) 2021, due to a broken ø6.5mm x 40mm reform ti modular non-cannulated - non-fluted screw (39-sg-6540).Both pieces of the broken screw were removed, and a larger screw was implanted.
 
Event Description
It was reported that a procedure was performed on (b)(6) 2021, utilizing the reform ti modular pedicle screw system.Subsequently, the patient underwent revision surgery on (b)(6) 2021, due to a broken ø6.5mm x 40mm reform ti modular non-cannulated - non-fluted screw (39-sg-6540).Both pieces of the broken screw were removed, and a larger screw was implanted.
 
Manufacturer Narrative
H3 device evaluation - the returned part was visually examined with the aid of a 5x loop.Multiple ratchet marks exist near one side of the fracture.Initial crack propagation is believed to have initiated in this area.Progression marks also exist.It appears that the screw broke via a fatigue failure.The cause for this can not be ascertained from this review and the details of the implantation were not made available.Review of device history records found twenty-five (25) pieces of lot 32245ps were released for distribution on 9/9/2020 with no deviation or anomalies.Two-year complaint history review (6.8.2019-6.8.2021) found this to be the only report for the reported part number.No corrective actions are being recommended at this time as this is the first reported failure for this part number.
 
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Brand Name
REFORM TI PEDICLE SCREW SYSTEM VERSION OR MODEL: 39-SG-6540
Type of Device
MODULAR BONE SCREW
Manufacturer (Section D)
PRECISION SPINE, INC.
2050 executive dr
pearl MS 39208
MDR Report Key12325227
MDR Text Key266835615
Report Number3005739886-2021-00045
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00840019940139
UDI-Public00840019940139
Combination Product (y/n)N
PMA/PMN Number
K150856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number39-SG-6540
Device Catalogue Number39-SG-6540
Device Lot Number32245PS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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