MAUDE Adverse Event Report: PRECISION SPINE, INC REFORM TI MODULAR; BONE SCREW, INTERNAL SPINAL FIXATION

Catalog Number 39-SK-6550

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.This report is number 1 of 2 mdrs filed for the same event (reference 3005739886-2023-00057 / 00058).

Event Description

It was reported that the patient underwent initial l5/s1 implantation of modular cannulated screws on (b)(6), 2023, in australia.Subsequently, the patient presented with pain, and it was identified that the screws in s1 had broken.Revision procedure was performed on (b)(6) 2023 during which it was noted that left s1 was broken mid-shaft (distal to the diameter transition).The proximal end of 39-sk-6550 was explanted, the distal fragment remains in the patient.A 39-sk-7580 shank (with tulip and set screw) were implanted at the iliac crest for additional strength and to avoid the fragment.No new screws implanted at s1 on either side.The right s1 shank was broken at approximately the diameter-transition.The proximal end of 39-sk-6545 was explanted and the distal fragment remains in the patient.A 39-sk-7570 shank (with tulip and set screw) were implanted at the iliac crest on the right side for additional strength and to avoid the fragment.The l5 screws were removed and replaced.

Event Description

It was reported that the patient underwent initial l5/s1 implantation of modular cannulated screws o (b)(6) 2023, in australia.Subsequently, the patient presented with pain, and it was identified that the screws in s1 had broken.Revision procedure was performed on (b)(6) 2023, during which it was noted that left s1 was broken mid-shaft (distal to the diameter transition).The proximal end of 39-sk-6550 was explanted, the distal fragment remains in the patient.A 39-sk-7580 shank (with tulip and set screw) were implanted at the iliac crest for additional strength and to avoid the fragment.The proximal end of 39-sk-6545 was explanted and the distal fragment remains in the patient.A 39-sk-7570 shank (with tulip and set screw) were implanted at the iliac crest on the right side for additional strength and to avoid the fragment.The l5 screws were removed and replaced.

Manufacturer Narrative

H3 device evaluation - s1 screw fractures were observed in a l5 - s1 procedure with decompression performed on one side.No innerbody was used as the disc was identified as calcified with no movement observed between l5 and s1.The fractured s1 screws were sent out for sem evaluation.The results of those assessments note the failure mode was via fatigue.Both fractures initiated in the minor diameter at remnant tooling edge discontinuities.Both s1 screws were cannulated ø6.5mm screws, it is unclear why the s1 implants failed via fatigue loading since it was noted that no movement was observed between l5 and s1.Some manner of introducing preloading / prestressing the screws as part of construct assembly or movement / instability between l5 and s1 would be needed to facilitate fatigue loading across the screws.Review of device history records found forty (40) pieces of this lot released for distribution on 11/4/2021 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for the reported part number.No corrective actions are being recommended.This report is number 1 of ? mdrs filed for the same event (reference 3005739886-2023-00057-1 / 00058-1).

• Brand Name: REFORM TI MODULAR
• Type of Device: BONE SCREW, INTERNAL SPINAL FIXATION
• 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: 17976975
• MDR Text Key: 326235021
• Report Number: 3005739886-2023-00057
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840019933636
• UDI-Public: 00840019933636
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39-SK-6550
• Device Lot Number: 38628PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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
• Patient Sex: Male