MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM POCT SYSTEM; ADJUSTMENT DRIVER

Model Number	55-IN-0060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information - unknown.Date of event - unknown.Occupation - other; sales & mkt assistant.Device evaluation - although initial information indicates that the device is available for evaluation, it has not yet been received by the manufacturer.Review of device history records found seventeen (b)(4) pieces of lot 00074rs were released for distribution on 4/3/2018 with no deviation or anomalies.Two-year complaint history review found this to be the only report for this lot.Further review did not identify a trend for reports of this nature for this part number.No conclusions can be drawn at this time.Should the product be received, a follow-up report will be filed following completion of investigation.
Event or Problem Description
It was reported that a procedure was performed in (b)(6), on an unknown date, utilizing the reform poct pedicle screw system.The tip of the adjustment driver, poct screw system (55-in-0060) broke while adjusting the screw.The broken piece was removed from the screw and the procedure was completed with no further issue.There was no patient injury or delay to the procedure reported.

• Brand Name: REFORM POCT SYSTEM
• Common Device Name: ADJUSTMENT DRIVER
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• MDR Report Key: 12267880
• Report Number: 3005739886-2021-00043
• Device Sequence Number: 17253628
• Product Code: HXX
• UDI-Device Identifier: 00840019926423
• UDI-Public: 00840019926423
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-IN-0060
• Device Catalogue Number: 55-IN-0060
• Device Lot Number: 00074RS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1