MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS; SCREW,FIXATION,BONE

Device Problem Migration (4003)

Patient Problems Pain (1994); Paralysis (1997)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The event date is unknown in 2020.This report is for an unk - screws: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a removal of implants due to hardware failure and severe complications on (b)(6) 2018.It was on (b)(6) 2016 when the patient underwent anterior cervical fusion, c3-c4 to c6-c7, c3-t1 posterior segmental fusion.The devices used were vectra t system and synapse system.But late (b)(6) 2016, the patient claims that he had difficulty swallowing, breathing, coughing blood, and felt burning pain.On (b)(6) 2017, the patient underwent esophagogastroduodenoscopy with foreign body removal.The patient also claimed to have undergone numerous procedures prior to this procedure.This procedure was performed for surveillance examination to prebiopsy the lesion.The surgeon tried to remove the foreign body using alligator forceps for grasping.But it was fully embedded into the wall of the esophagus.Thus, the procedure was terminated.The patient tolerated the procedure well without any immediate post-procedure complications.On (b)(6) 2017, another esophagogastroduodenoscopy was performed by another surgeon.It showed that the patient appears to have a plate which was used in the cervical fusion eroding into the cervical esophagus.The esophageal lumen was distorted.However, ent evaluation would be appropriate prior to any kind of intervention so the procedure was then terminated.On (b)(6) 2017, the patient went for a consultation and was referred to another doctor.On (b)(6) 2018, the patient underwent removal of instrumentation from c4-c7, acd from c2-c4 with decompression of epidural abscess, c3 corpectomy (90%), anterior cervical instrumentation from c2-c4 with incision and drainage.On (b)(6) 2018, the patient underwent posterior segmental instrumentation of c2 and c3, laminectomy entire c3 and inferior c2 lamina, removal of hardware including rods and broken t1 pedicle screws bilaterally and posterior segmental instrumentation with bilateral pedicle screws t2 and t3.The procedure and the patient outcome were unknown.This complaint involves 4 devices.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was not received.The device is not available for the investigation and the customer is retaining the product.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10071288
• MDR Text Key: 191466296
• Report Number: 2939274-2020-02433
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR