MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.2MM TI DUAL-OPENING SCREW 45MM THRD LENGTH F/6.0MM RODS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 499.223

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: mni, nkb, kwq, mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Part number: 499.223, lot number: 6965910, date of manufacture: 06/20/2012, place of manufacture: (b)(4), part expiration date: n/a (nonsterile), list of nonconformances: none.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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) 2020, the patient underwent uss dual opening hardware removal surgery due to broken hardware.The surgeon removed the posterior uss dual opening hardware that was implanted in the year 2012 due to a thoracolumbar spine fracture.There were two (2) issues with the hardware from the 2012 surgery.The left rod was broken just cranial to the l2 screw.Also, the right l2 screw was broken just below the head of the screw.It is unknown when the hardware broke.There were no screws placed at l1 the level of the fracture.All the hardware was easily removed, but the tip of the broken screw remains in the right l2 pedicle.The surgeon decided that there is no problem leaving this broken screw in the patient and that there was a risk of harm to the patient by trying to remove the broken screw.The patient has successfully healed and the removal was successfully completed.Concomitant device: locking/set screws: uss (part number unknown, lot unknown, quantity unknown), 6.0mm ti hard rod 100mm (part number 498.104 , lot 6784859, quantity 1).This report involves one (1) 6.2mm ti dual-opening screw 45mm thrd length f/6.0mm rods.This is report 2 of 2 for (b)(4).

• Brand Name: 6.2MM TI DUAL-OPENING SCREW 45MM THRD LENGTH F/6.0MM RODS
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11132658
• MDR Text Key: 225570755
• Report Number: 2939274-2021-00072
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034792927
• UDI-Public: (01)10705034792927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 499.223
• Device Catalogue Number: 499.223
• Device Lot Number: 6965910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 6.0MM TI HARD ROD 100MM; UNK - LOCKING/SET SCREWS: USS
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR