MAUDE Adverse Event Report: REPUBLIC SPINE, LLC DARK STAR PEDICLE SCREW SYSTEM; THORACOLUMBAR PEDICLE SCREW SYSTEM

Model Number 100008-8570

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device is being returned to the manufacturer for evaluation but could not be delivered and evaluation completed within the 5-day reporting period.Therefore, a supplement will be filed, as needed, to provide the results of the evaluation.Review of the device history record was completed.The inspection records show that the device lot was inspected according to an appropriate sampling plan.Eight (8) of the (4) devices failed due to particulate debris.A non-conformance was documented and dis-positioned all (8) devices to be scrapped and for all remaining devices in the lot to be inspected (100% inspection).Results of 100% inspection is that all devices met the acceptance criteria.Therefore, it is concluded that the subject pedicle screw meets all specifications as defined in the inspection procedure.Parts involved with this complaint are: part number / lot / udi/ device description; 100008-8570 / 19407 / b0751000088570 / 8.5 dia x 70mm low top pedicle screw, 100220-8540 / 24807 / b0751002208540 / 8.5 dia x 40 mm mis screw.Due to technical difficulties, this report is unable to be sent via the esg on time.This report is finalized as of 7/16/2020, but will be sent to the fda via esg as soon as possible.

Event Description

Pedicle screws and rods placed t10 - ilium bilaterally in the spine.Tulip dissociated from screw located in the right ilium (screw remains in the bone).Screw in s1 pulled out of bone.History leading to event is as follows: (b)(6) 2020: date of initial surgery.Pedicle screws and rods placed bilaterally from t10 to ilium.Intra-operatively, screws were inserted and removed from l5 (right side) and s1 (right side) due to poor bone quality.Additionally, surgeon noted tulip head splayed at l5 (left side) during insertion so l5 screw was removed and replaced intra-operatively.Upon conclusion of surgery, all screws were anchored to bone and construct was rigid, to surgeon liking.(b)(6) 2020: patient went to emergency room due to lower back pain.X-ray showed the screw located in right ilium had disassembled (tulip head popped off) but radiologist read the x-ray incorrectly, did not note an issue and sent the patient home.Patient left emergency room without intervention.(b)(6) 2020: patient contacted operating surgeon.Surgeon instructed the patient to go to the emergency room.Revision surgery scheduled for (b)(6) 2020.Surgeon notified republic spine sales representative of the event.According to surgeon, when patient contacted him in july, she did not mention a potential contributing event (e.G., fall, slip, etc.).(b)(6) 2020: revision surgery completed successfully.Since the patient did not receive medical/surgical intervention for approximately one month after the right ilium screw tulip head had popped off, the surgeon removed and replaced all screws and rods for the entire construct (including the right ilium screw) and s1 screw that backed out).New, larger (rescue) screws with double lead thread were utilized for the revision surgery.The surgeon replaced all screws with a competitor product as a precaution, due to the patient being mobile with an incomplete implant construct for approximately one month and because another manufacturer's screw system was used and mixing screws from two different systems is not recommended.

• Brand Name: DARK STAR PEDICLE SCREW SYSTEM
• Type of Device: THORACOLUMBAR PEDICLE SCREW SYSTEM
• Manufacturer (Section D): REPUBLIC SPINE, LLC; 2424 n federal hwy; ste 257; boca raton, fl
• Manufacturer (Section G): REPUBLIC SPINE, LLC; 2424 n federal hwy; ste 257; boca raton, fl
• Manufacturer Contact: james doulgeris ; 2424 n federal hwy; ste 257; boca raton, fl ; 5125461
• MDR Report Key: 10290357
• MDR Text Key: 199989263
• Report Number: 3011796723-2020-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100008-8570
• Device Catalogue Number: DS-8570
• Device Lot Number: 19407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 68 YR
• Patient Weight: 113