MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: SPINE; PLATE,FIXATION,BONE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown plate: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 surgeon was attempting to remove an unknown plate that was in a patient.The surgeon attempted to remove another unknown screw and while the surgeon was doing it, the reporter have pulled another set.The reason for removal of the plate and screws was due to adjacent level disc disease.They were removing a vectra-t plate.This was a revision anterior cervical discectomy and fusion (acdf) for adjacent level disease.Bone was encased over the plate and needed to be removed.Various tools were utilized to remove the bone including bovie and curettes.They also used the screw head cleaning tool and extraction screwdriver from the vectra-t plating system.There were fragments generated from broken device and the removal of the broken, damaged device or fragments was completed with difficulty as it required some additional cleaning of bone from the plate and screw.The procedure was successfully completed.The surgery proceeded with a surgical delay of thirty (30) seconds.There was no patient harm.This complaint involves unknown number of devices.This report is for one (1) unk - plates: spine.This is report 1 of 2 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.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 surgeon attempted to remove an unknown vectra-t plate and screw from the patient.The reason for removal of the plate and screws was due to adjacent level disc disease.This was a revision acdf for adjacent level disease.Bone was encased over the plate and needed to be removed.Various tools were utilized to remove the bone including bovie and curettes.They also used the screw head cleaning tool and extraction screwdriver from the vectra-t plating system.There were fragments generated from the broken device.Removal of the broken device and fragments was completed.The procedure was successfully completed with a surgical delay of thirty (30) seconds.The implants were successfully removed.

• Brand Name: UNK - PLATES: SPINE
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10289502
• MDR Text Key: 199283152
• Report Number: 2939274-2020-03243
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/17/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS; UNK - SCREWS
• Patient Outcome(s): Required Intervention