MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM POCT SYSTEM; STANDARD CAP SCREW

Model Number	55-LS-0100
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information - unknown.Reporter 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 the patient underwent a c1-c2 bilateral extension procedure on (b)(6) 2020, utilizing the reform poct pedicle screw system.Two-week post operation x-rays looked good, 4-week x-rays shows top bilateral set screws backed out, with loss of correction.Revision procedure to address set screw backout was performed on (b)(6) 2020, during which two (2) 55-pa-4040 4.0 x 40mm polyaxial screws, eight (8) 55-ls-0100 cap screw posterior cervical systems, and two (2) 55-lt-5080 3.5 x 80mm lordotic rod ti were removed and replaced with the same sizes.
Additional Manufacturer Narrative
H3 device evaluation - returned implants were reviewed along with the post-op x-ray images.Witness marks were found on the underside of all screws, demonstrating locked cap screws in the construct.A partially missing tulip thread was found on one of the two returned 55-pa-4040 screws, demonstrating the forced removal of the set screw post-procedure.Root cause could not be determined.Review of device history records found 458 pieces of lot 27471ps released for distribution on 12/23/2010 with no deviation or anomalies.Two-year complaint history review (6.26.2018-6.26.2020) found this to be the only report for this part number.No corrective actions are recommended.
Event or Problem Description
It was reported that the patient underwent a c1-c2 bilateral extension procedure on (b)(6) 2020, utilizing the reform poct pedicle screw system.Two-week post operation x-rays looked good, 4-week x-rays shows top bilateral set screws backed out, with loss of correction.Revision procedure to address set screw backout was performed on (b)(6) 2020, during which two (2) 55-pa-4040 ø4.0 x 40mm polyaxial screws, eight (8) 55-ls-0100 cap screw posterior cervical systems, and two (2) 55-lt-5080 ø3.5 x 80mm lordotic rod ti were removed and replaced with the same sizes.

• Brand Name: REFORM POCT SYSTEM
• Common Device Name: STANDARD CAP SCREW
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• MDR Report Key: 10303796
• Report Number: 3005739886-2020-00018
• Device Sequence Number: 2576825
• Product Code: NKG
• UDI-Device Identifier: 00815362023907
• UDI-Public: 00815362023907
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 55-LS-0100
• Device Catalogue Number: 55-LS-0100
• Device Lot Number: 27471PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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