MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM TI PEDICLE SCREW SYSTEM VERSION OR MODEL: 39-SG-6540; MODULAR BONE SCREW

Model Number	39-SG-6540
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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.

• Brand Name: REFORM TI PEDICLE SCREW SYSTEM VERSION OR MODEL: 39-SG-6540
• Common Device Name: MODULAR BONE SCREW
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 12325227
• Report Number: 3005739886-2021-00045
• Device Sequence Number: 14563284
• Product Code: NKB
• UDI-Device Identifier: 00840019940139
• UDI-Public: 00840019940139
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 39-SG-6540
• Device Catalogue Number: 39-SG-6540
• Device Lot Number: 32245PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention