MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P VA IMPLANT 8MM HEIGHT CONVEX-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.647.138S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s height reported as 175 cms.This patient information is unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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, patient underwent a c4-c7 anterior cervical fusion procedure.During the procedure, the zero-p variable angle (va) implant 8mm height convex-sterile was inserted at the c4-c5 level.Upon insertion with the insertion device, the plate disengaged from the peek spacer.The surgeon was unable to completely re-engage the plate to the implant after numerous attempts.A new zero-p va implant was requested as the surgeon was uncomfortable with trying to force the implant on.Upon removing the zero-p va implant from the sterile field, the sales consultant was able to disengage the implant completely with considerable force.The plate seemed to be stuck halfway down the track on the peek spacer.A new zero-p va of the same size was implanted with no issues.The inner shaft for extraction screwdriver was reportedly broken, and the fragment is still located inside of a titanium cervical self retaining screw that was not implanted into the patient.There was no patient consequence reported.The procedure was successfully completed with a surgical delay of 10 minutes.Patient outcome was good.Concomitant device/s reported: insertion device (part# 03.647.963, lot# unknown, quantity# 1), peek spacer (part# unknown, lot# unknown, quantity# 1), screws: zero-p va (part# 04.613.518, lot# unknown, quantity# unknown).This report is for one (1) zero-p va implant 8mm height convex-sterile.This is report 1 of 2 for complaint (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.A device history record (dhr) review was conducted for part: 04.647.138s, lot: l791910: manufacturing site: mezzovico , release to warehouse date: 01.March 2018 , expiry date: 01.Feb.2028.The device history record shows this lot of (b)(4) pieces 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.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.Complainant part is not expected to be returned for manufacturer review/investigation.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: ZERO-P VA IMPLANT 8MM HEIGHT CONVEX-STERILE
• 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: 7739936
• Report Number: 2939274-2018-53159
• Device Sequence Number: 13732659
• Product Code: OVE
• UDI-Device Identifier: 10705034750828
• UDI-Public: (01)10705034750828
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.647.138S
• Device Catalogue Number: 04.647.138S
• Device Lot Number: L791910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/30/2018
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 81