MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Model Number	04.617.127S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.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.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a spinal fusion procedure performed on (b)(6) 2018, a zero-p implant 7mm height split apart prior to final implantation in the patient.The implant was therefore removed from use and another readily available implant was used instead.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.
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 review was performed for the subject device: part no.: 04.617.127s , lot no.: 8271065 , manufacturing location: mezzovico , release to warehouse date: 18.Feb.2013 , expiry date: 01.Feb.2023.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A investigation was performed for the subject device: the returned implant was received at customer quality (cq) in assembled condition.The peek spacer component was able to be separated from the titanium aluminum niobium (tan) plate component at cq by sliding the two components apart with above average manual force.Visual inspection under 5x magnification revealed wear marks on the tan component in areas consistent with attempted implantation (impaction) and removal.The returned implant is included in the zero-p anterior cervical system.Technique guide provides instructions for attaching the spacer to the inserter and for inserting the implant into the disc space.Excessive impaction may have caused the dissociation.The segment may not have been distracted enough to allow smooth entry into the disc space creating the need for the excessive impaction during insertion.Details on the intra-operative conditions are unknown however and so the root cause is unable to be definitively determined.The slot widths of the returned peek spacer component were measured at cq and ranged from 0.95mm - 0.96mm (calipers ca592) which is within specification of 1.0mm +/-0.05mm per component drawing.The width of the returned peek spacer component measured 13.80mm at cq (calipers ca592) which is within specification of 13.75mm +/-0.05mm per component drawing.The tang widths of the returned tan plate component were measured at cq and ranged from 0.88mm - 0.89mm (calipers ca592) which is within specification of 0.9mm +0.0/-0.05mm per component drawing.The distance between the tangs of the returned tan plate component measured 12.56mm at cq (calipers ca592) which is within specification of 12.544mm +/-0.05mm per component drawing.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The material was determined to be conforming at the time of manufacture based on review of the dhr.The zero-p cage product drawing was reviewed during this investigation.The plate and spacer interconnection is designed to allow for detachment in order to decouple stresses in the plate from the spacer to prevent breakage.No product design issues or discrepancies were observed.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.

• Brand Name: ZERO-P IMPLANT 7MM HEIGHT LORDOTIC-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: 7296270
• Report Number: 2939274-2018-50786
• Device Sequence Number: 11133762
• Product Code: OVE
• UDI-Device Identifier: 10705034741901
• UDI-Public: (01)10705034741901(17)EXPLANTATIONDATEUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2018

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 Expiration Date: 02/01/2023
• Device Model Number: 04.617.127S
• Device Catalogue Number: 04.617.127S
• Device Lot Number: 8271065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/09/2018; 04/25/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 03/13/2018; 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1