MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; MODULAR BONE SCREW, CANNULATED

Catalog Number	39-SK-6545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other - 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 l4/l5/s2a1 procedure was performed in australia on (b)(6) 2022, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographs showed compression of the construct and a broken screw in l4, right side.Revision procedure was performed on (b)(6) 2024, during which the broken 45mm reform ti modular cannulated screw (39-sk-6545) was confirmed and it was noted that the left side l4 screw showed significant loosening.Both the proximal and distal ends of the broken screw were removed and replaced along with the loose screw on the right side.In addition, screws were also placed in the two levels above with the remainder of the original construct left in place.Image provided shows cage migration in the disc space just under the broken screw.
Additional Manufacturer Narrative
H3 device evaluation - both the proximal and distal segments of the broken screw were returned for evaluation.The distal segment fracture site is marred.The marring is likely due to tools used to help extract that segment from the pedicle.Due to this visual assessment of those surfaces are not practical other than noting that the fracture is along the screw's minor diameter.The proximal segment was reviewed with the aid of a 5x loop.It is believed that the screw fractured via low cycle fatigue.The cause for this fracture is believed to be related to the condition of the construct.Instability appears to exist with the complaint noting that the cage had migrated and as evidenced in the x-ray that was provided.The x-ray shows signs of cage looseness (darkness around the cage).After more than 1 year and 9 months this revision took place.Review of device history records found 243 pieces of this lot released for distribution on (b)(6) 2020 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this product family.No corrective actions are recommended at this time.
Event or Problem Description
It was reported that a l4/l5/s2a1 procedure was performed in australia on (b)(6) 2022, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographs showed compression of the construct and a broken screw in l4, right side.Revision procedure was performed on (b)(6) 2024, during which the broken 45mm reform ti modular cannulated screw (b)(6) was confirmed and it was noted that the left side l4 screw showed significant loosening.Both the proximal and distal ends of the broken screw were removed and replaced along with the loose screw on the right side.In addition, screws were also placed in the two levels above with the remainder of the original construct left in place.Image provided shows cage migration in the disc space just under the broken screw.

• Brand Name: REFORM TI MODULAR
• Common Device Name: MODULAR BONE SCREW, CANNULATED
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: mike dawson ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 18924238
• Report Number: 3005739886-2024-00014
• Device Sequence Number: 12627223
• Product Code: KWP
• UDI-Device Identifier: 00840019933629
• UDI-Public: 00840019933629
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 39-SK-6545
• Device Lot Number: 32839PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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