MAUDE Adverse Event Report: SYNTHES GMBH ZERO-P VA IMPLANT 5MM HEIGHT CONVEX-STERILE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number 04.647.135S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Event year is reported as 2021.However the exact date of event is unknown.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.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a surgery on an unknown date in 2021, the surgeon did the lordotic tests and was satisfied with the height of 5mm.But, when surgeon applied the convex implant he did not feel sufficient anchorage and had to chose 2 lordotic cages.This report is for one (1) zero-p va implant 5mm height convex-sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint#: (b)(4).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.H10 additional narrative: b5: updated additional event information.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 Description

Additional event information: the doctor had to test the height using a lordotic trial because no convex trials were available.There was no malfunction about zero-p va, but the anatomy of the convex implant didn't provide enough anchorage when comparing with the lordotic trial of the same height.The patient outcome was ok.The procedure was completed successfully with 10-minutes delay.

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.H6: product code 04.647.135s, lot: 27p3104, manufacturing site: mezzovico, release to warehouse date: november 27, nov 2019, expiry date: november 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

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.H3, h6: a product investigation was completed: visual inspection of the complaint device showed no defect.To test how secure were the spacer and the plate, both were wiggled and tried to be pulled apart.Both components remained firmed and stayed connected.The complaint condition could not be confirmed.No dimensional inspection was performed as there was no damage that warranted a dimensional inspection.The current and manufactured to drawing was reviewed; no design issues or discrepancies were identified.This complaint is not confirmed as the complaint device was inspected and found to have no defect.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

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 Description

It was further reported that the convex implant was not secured once the surgeon took off the distraction.The surgeon felt that the height of the final implant did not match the height of the trial.

• Brand Name: ZERO-P VA IMPLANT 5MM HEIGHT CONVEX-STERILE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11624374
• MDR Text Key: 246057321
• Report Number: 8030965-2021-02623
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 07611819405332
• UDI-Public: (01)07611819405332
• Combination Product (y/n): N
• PMA/PMN Number: K112068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.647.135S
• Device Lot Number: 27P3104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 09/14/2021
• Patient Sequence Number: 1