MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X50MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186770450

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Physician indicated that screw shaft was inside the cup and because of that it was impossible to implement the rod.No consequences for the patient reported.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves one (1) device.

Event Description

The physician indicated that screw shaft was inside the cup and therefore it was impossible to implement the rod.There were no consequences to the patient reported.There was surgical delay of 15 to 20 minutes, fragments were generated however they were easily removed.The procedure was successfully completed.Patient status is unknown.

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.Additional narrative: adverse event problem: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition could not be confirmed as the image did not provide enough clarity to determine if the proximal portion of the screw fell apart, however the distal tip is broken.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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.Corrected information: patient code and device code.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

Product complaint # (b)(4).Udi: (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.Device was not returned for evaluation.Although lot number was provided.Manufacturing records could not be found using this lot number.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

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.H3, h6: device history lot: null,a review of the receiving inspection (ri) for viper prime cfxfen xtab 7x50mm-sterile was conducted identifying that lot number tbvnb was released in a single batch.Batch1: lot qty of (b)(4) were released on 02 jul 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review null,the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.H3, h6: investigation summary updated event description: physician indicated that screw shaft was inside the cup and because of that it was impossible to implement the rod.No consequences for the patient reported.There was surgical delay of 15 to 20 minutes.Fragments were generated and were easily removed.The procedure was successfully completed.Patient status is unknown.Customer quality investigation: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s) from the attachments (1 image(s) from the attachment(s) located in notes & attachments section of the product complaint).The image(s) was reviewed, and the complaint condition could not be confirmed as the image did not provide enough clarity to determine if the proximal portion of the screw fell apart, however the distal tip is broken.As the implant(s) was not returned an as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation could not be performed as the lot number could not be determined from the provided image.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.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.,background: 10/08/2019 updated event description: the physician indicated that the screw shaft was inside the cup and because of that, it was impossible to implement the rod.No consequences for the patient-reported.There was a surgical delay of 15 to 20 minutes.Fragments were generated and were easily removed.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown) this complaint involves one (1) device.Investigation flow: functional/device interaction.Visual inspection: the viper prime cfxfen xtab 7 x 50 mm (p/n: 186770450, lot #: tbvnb) was returned and received at us cq, upon visual inspection, it was observed that the screw head was loose.There was damage on the head of the verse screw, however, this damage is expected and due to the removal of expedium verse screw reduction tabs at the completion of the procedure using tab remover per expedium verse spinal system.The remaining features of the device, including the threads, displayed no signs of damage or defect.Functional test: functional test was not performed on the returned device due to the device received by itself and the removal of expedium verse screw reduction tabs.Dimensional inspection: a dimensional inspection was not performed on the screw head as the internal components were inaccessible without destruction of the device.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.The device received was loose.Hence confirming the allegation.Investigation conclusion : the complaint condition is confirmed for the viper prime cfxfen xtab 7 x 50 mm (p/n: 186770450, lot #: tbvnb).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.

• Brand Name: VIPER PRIME CFXFEN XTAB 7X50MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9193473
• MDR Text Key: 176843032
• Report Number: 1526439-2019-52250
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509624
• UDI-Public: (01)10705034509624
• Combination Product (y/n): N
• PMA/PMN Number: K170543
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770450
• Device Catalogue Number: 186770450
• Device Lot Number: TBVNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1