MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.647.876
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of implant is an unknown date in (b)(6) 2016.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2018, a revision anterior cervical fusion was performed due to failure to lock of a cervical spine self-tapping zero profile variable angle (va) screw.The hardware was implanted in (b)(6) 2016.On an unknown post-operative date, a year after initial implantation, it was discovered that the screw had backed out from the zero profile variable angle plate.The screw was successfully removed with no harm to the patient.There was no surgical delay.Concomitant device: zero-p va plate (part: unknown, lot: unknown, quantity: 1).This report is for a 3.7mm titanium (ti) cervical spine screw.This is report 1 of 1 for (b)(4).
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.Device history (lot) part: 04.647.878 , lot: 8530230 , manufacturing site: mezzovico, release to warehouse date: 19.July 2013 , expiry date: 01.Aug.2026.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary the complaint cannot be confirmed as there is no image showing that the screw migrated.Functional test: the complaint could not be replicated, and the complaint could not be confirmed since the screw was returned by itself.Dimensional inspection: dimensional analysis was completed, the head diameter of the screw measured 4.39 mm and the overall length measured 18.14 this is within specifications the complaint condition is not confirmed as there was no x-ray sent to us cq showing the migrated screw.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
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.H10 additional narrative: 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: 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 16MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8010380
• Report Number: 2939274-2018-54645
• Device Sequence Number: 1394685
• Product Code: OVE
• UDI-Device Identifier: 10705034751429
• UDI-Public: (01)10705034751429
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: 04.647.876
• Device Catalogue Number: 04.647.876
• Device Lot Number: 8530230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 12/05/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/16/2018; 12/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91