MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.(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 or Problem Description
It was reported that on (b)(6) 2020 that an unknown vectra-t plate and unknown screw were removed due to adjacent level disc disease.This was a revision anterior cervical discectomy and fusion (acdf) for adjacent level disease.The bone was encased over the plate and needed to be removed.Various tools were utilized to remove the bone including bovie and curettes.The screw head cleaning tool and extraction screwdriver from the vectra-t plating system were also used.There were fragments generated from the broken device which were difficult to remove and required some additional cleaning of the bone from the plate and screw.The procedure was successfully completed.The surgery proceeded with a surgical delay of thirty (30) seconds.The patient was not harmed.This report is for one (1) 4.0mm ti cerv self-retain scr slf-drlg/variable angle 18mm.This is report 3 of 3 for (b)(4).
Event or Problem 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.
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 18MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10347144
• Report Number: 2939274-2020-03328
• Device Sequence Number: 14194157
• Product Code: KWQ
• UDI-Device Identifier: 10705034737669
• UDI-Public: 10705034737669
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 04.613.518
• Device Catalogue Number: 04.613.518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention