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

Model Number 39-PA-1050

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Patient information - unknown.Lot number - unknown.Initial reporter 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 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 3 of 3 mdrs filed for the same event (reference 3005739886-2022-00011 / 00013).

Event 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 (hxx-39-0001) 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.

Event 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.

Manufacturer Narrative

This report is for the screw that the head twisted off during attempted insertion.Product was received on 4/28/2022 providing additional information.The following information was corrected: b1 report type, b5 describe event or problem, d4 catalog, lot & unique device identifier, d10 device availability, g5 pma/510(k) number, h3 device evaluated by manufacturer & h4 device manufacture date product evaluation is in process, a follow-up medwatch report will be submitted upon completion of investigation to provide results.This report is number 3 of 3 mdrs filed for the same event (reference 3005739886-2022-00011-1 / 00013-1).

Manufacturer Narrative

H3 device evaluation - the broken screw was examined by eye and with the aid of a 5x loop.The broken polyaxial screw assembly is still affixed to the driver that was used for implantation.This driver's locking feature remains in the locked position.The screw fracture is normal to its longitudinal axis.The failure mode appears to be in agreement with a ductile torsional overload.The driver that is attached to the broken screw is for reform polyaxial screws that incorporate a t20 drive feature vs the t25 drive feature incorporated in reform ti polyaxial screws.This does not appear to be a factor in the screw failure in that the locked screwdriver transmitted the torque which brought the screw to a 85% seated position prior to screw neck failure.The lock feature was depressed to release the lock but the tension in the mechanism held the lock in place.Review of device history records found ten (10) pieces of this lot released for distribution on 1/19/2019 with no deviation or anomalies.Two-year complaint history review found this to be the only report of screw failure for any part number in the reform ti pedicle screw family of part numbers.No corrective actions are recommended at this time.This report is number 3 of 3 mdrs filed for the same event (reference (b)(4).

Event 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
• Type of Device: 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: 14138141
• MDR Text Key: 298904092
• Report Number: 3005739886-2022-00013
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840019902427
• UDI-Public: 00840019902427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39-PA-1050
• Device Catalogue Number: 39-TP-1045
• Device Lot Number: 21918PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention