MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.617.816
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2018.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
Patient reported complaint.It was reported that on (b)(6) 2018, a revision surgery was done involving a depuy synthes zero natural device due to pain and risk that unknown screws would back-up into patient's esophagus.Device was originally implanted into the patient's neck on (b)(6) 2018.Cervical neck procedure done involved discs 2-3 and 3-4.The surgeon advised that unknown screws or pins that were used were inserted into the plate and locked into place.When the patient went for a follow-up appointment on an unknown date (2 months post-operatively), x-ray revealed that screws were backed out and failed to click in properly which resulted in an unknown emergency surgery.The surgeon¿s report documented hardware malfunction and claims that she never heard of screws backing out before.Patient was taken off blood thinners prior to the emergency procedure.The patient was not informed to resume blood thinners post-operatively which resulted in having circulation problems in the legs, blood clots, and may need amputations.It is unknown if there was surgical delay.Patient is in constant pain with attached cervical stimulator and neck brace.Concomitant devices: zero-p natural plate size 7 with assembly tool (part: 04.617.707s, lot: h663029, quantity: 1) this report is for a 3.0mm ti cervical spine locking screw 16mm.This is report 2 of 2 for (b)(4).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 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: 8223668
• Report Number: 2939274-2019-55728
• Device Sequence Number: 1656696
• Product Code: OVE
• UDI-Device Identifier: 10705034742298
• UDI-Public: (01)10705034742298
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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 Model Number: 04.617.816
• Device Catalogue Number: 04.617.816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR