MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC/LARGE-STERILE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.647.226S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is the sales representative.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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) 2019, during anterior cervical fusion there were two (2) large footprint lordotic mm zero- profile variable angle (zero-pva) implants where the connected part were separated, where the peek meets the plate during insertion.It is unknown if there was a surgical delay.No fragments generated.The procedure was completed by switching down to the standard size of the implant.Another set of zero pva implants were used.The procedure was successfully completed.There was no patient consequence.Concomitant devices reported: unk - screws: zero-p va (part # unknown, lot # unknown, quantity unknown).This report is 2 of 2 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 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
Updated: there was a 15 minutes surgical delay.
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.Visual inspection: the device shows minimal wear consistent with the usage of the device which would not contribute to the complaint condition.The complaint condition is not confirmed.No device failure/defect was identified.Functional test: a functional test in effort to replicate the reported complaint condition was performed at customer quality (cq).No functional issues were identified.The complaint cannot be replicated with the returned devices.Dimensional inspection: a dimensional inspection was not performed because the functional test was passed and no device related issues were identified.The design, materials, and finishing processes were found to be appropriate for the intended use of this device.Document/ specification review: the following drawing(s) was reviewed: ¿zero-p va large size 5 -12 assembly zero-p va large¿ ¿zero-p va large size 5-12 assembly zero-p va large¿ a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation conclusion: this complaint is not confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique, or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H4 device history review: part: 04.647.226s-us.Lot: 4l31592.Manufacturing site: mezzovico.Release to warehouse date: 30.April 2019.Expiry date: 01.April 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.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 6MM HEIGHT LORDOTIC/LARGE-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: 8780882
• Report Number: 2939274-2019-59125
• Device Sequence Number: 14119881
• Product Code: OVE
• UDI-Device Identifier: 10705034751207
• UDI-Public: (01)10705034751207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 06/14/2019

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: 04.647.226S
• Device Catalogue Number: 04.647.226S
• Device Lot Number: 4L31592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/13/2019; 08/29/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/13/2019; 08/13/2019; 09/19/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: ZERO-P VA; UNK - SCREWS: ZERO-P VA; UNK - SCREWS: ZERO-P VA
• Outcome Attributed to Adverse Event: Required Intervention