MAUDE Adverse Event Report: PRECISION SPINE, INC. REFORM PEDICLE SCREW SYSTEM; BONE SCREW INTERNAL SPINAL FIXATION SYSTEM,

Model Number	39-PA-1050
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: unknown.Lot number: unknown.If implanted, give date: unknown.Occupation: other; sales representative.Device manufacture date: unknown.Device evaluation - although information received indicates that the product is available for evaluation, it has not been received so product evaluation is not possible at this time.Without lot identification, manufacturing history review and lot specific complaint history review were not possible.Two-year complaint history review found this to be the only report for the 39-pa-xxxx family of screws.Without the ability to examine the explanted screw, no conclusions can be drawn as to the cause of the reported breakage.Should the product be received, a follow-up medwatch report will be submitted.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2022-00013).
Event or Problem Description
It was reported that the patient underwent a revision procedure on (b)(6) 2022, to address a broken reform pedicle screw, attributed to non-fusion.The original implantation date was not provided.The existing construct was removed and upon attempted insertion of a of a reform 10.5 x 50mm polyaxial pedicle screw (39-pa-1050) in a newly prepared pedicle, the tip of the reform polyaxial driver ((b)(4)) broke off in the head of the screw.The screw was then removed and successfully replaced with another screw using a second driver in the set.Subsequently, while implanting another reform 10.5 x 50mm polyaxial pedicle screw (39-pa-1050) the screw was 85% seated when the head of the screw sheared off at the neck between the screw head and threaded shaft.The threaded shaft was left in the patient's bone and the pedicle was left un-fixated.The construct was successfully completed with no harm to the patient.There was a delay of one hour because of the reported malfunctions.
Additional Manufacturer Narrative
This report is for the screw the broke post-operative, resulting in the revision procedure.The product was not returned, and no part/lot identity was provided.Corrected data as follows: b5 description of event or problem, d4 catalog number, d4 unique device identifier - unknown without part number, h3 if other, specify no conclusions can be drawn regarding the cause of the broken screw, although information provided indicates the patient was non-union at the time of revision.This report is number 1 of 3 mdrs filed for the same event (reference 3005739886-2022-00011-1 / 00013-1).
Event or Problem Description
It was reported that the patient underwent a revision procedure on (b)(6), 2022 to address a broken reform pedicle screw, attributed to non-fusion.The original implantation date was not provided.The existing construct was removed and upon attempted insertion of a of a reform ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) in a newly prepared pedicle, the tip of the t20 polyaxial driver reform pedicle screw system (39-sp-0730) broke off in the head of the screw.The screw was then removed and successfully replaced with another screw usinig a second driver in the set.Subsequently, while implanting another ø10.5mm x 45mm polyaxial screw assembly (39-tp-1045) the screw was 85% seated when the head of the screw sheared off at the neck between the screw head and threaded shaft.The threaded shaft was left in the patient's bone and the pedicle was left un-fixated.The construct was successfully completed with no harm to the patient.There was a delay of one hour because of the reported malfunctions.

• Brand Name: REFORM PEDICLE SCREW SYSTEM
• Common Device Name: BONE SCREW INTERNAL SPINAL FIXATION SYSTEM,
• Manufacturer (Section D): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC.; 2050 executive dr; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive dr; pearl, MS 39208 ; 6014204244
• MDR Report Key: 14138139
• Report Number: 3005739886-2022-00011
• Device Sequence Number: 6254186
• Product Code: NKB
• UDI-Device Identifier: 00815362028957
• UDI-Public: 00815362028957
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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-PA-1050
• Device Catalogue Number: 39-XX-XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown