MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY STENT-LARGE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.502S

Device Problems Difficult to Open or Close (2921); Device Handling Problem (3265)

Patient Problems No Patient Involvement (2645); No Code Available (3191)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device returned.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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.G510(k) pending clearance - spine.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that dr.San millan try to implant the vbs system and the stent was unable to open properly, the surgery was delayed 20 minutes due to the reported event and had to change the stent.Procedure was successfully completed and no fragments generated.Patient status/ outcome / consequences is unknown.Medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: this complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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, h4, h6: part: 09.804.502s, lot: 0218016, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 03.Apr.2018, expiry date: 01.Mar.2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Hoto/x-ray video review: based on the received x-ray video, the complaint condition that a pressure could not be built up, can be confirmed.We have forwarded the received information to the manufacturer biotronik for investigation, find the statement below: results + date: it was reported that the physician attempted to use the complaint instrument, but the stent did not open properly.Review of the lot release verification that the complaint instrument was manufactured according to specifications and passed all in -process inspections.The delivery system of the complaint instrument was returned without the stent.However, stent imprints on the balloon surface indicate that the stent was initially crimped on the balloon.During the investigation pressure could not be built up; at about two to three (2-3) atm the balloon opened and a fine water jet become apparent.Microscopic inspection of the balloon revealed a pinhole in the centre of the balloon.Several scratches and surface abrasions were observed at various position on the balloon surface.Root cause process category: base on these findings it seems likely that the root cause for the complaint event is related to the patient¿s anatomy (i.E.Balloon damaged by sharp solid bone fragments).H11: corrected data: b6: this event report is from (b)(6).E1: the initial reporter country code is (b)(6).H6 patient code updated from 2645 to 3191 to capture surgery prolonged.H6 patient code updated from 3265 to 2921.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.B3: updated event date to (b)(6) 2019.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: VERTEBRAL BODY STENT-LARGE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9137160
• MDR Text Key: 160665306
• Report Number: 8030965-2019-68867
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819432628
• UDI-Public: (01)07611819432628
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 09.804.502S
• Device Lot Number: 0218016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/15/2019
• Patient Sequence Number: 1
• Patient Age: 71 YR