MAUDE Adverse Event Report: SYNTHES SELZACH VBS MEDIUM; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.501S

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.The exact surgery date was not communicated by surgeon.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Device is not distributed in the united states.A device history record review was performed for the subject device lot number 0117020.Manufacturing location: (b)(4).Date of manufacture: 09 march 2017.Expiration date: 01 february 2020.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.(b)(4).During surgery upon inflating the balloon in the vertebral body stent (vbs), the surgeon noticed no pressure build up was possible.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during surgery upon inflating the balloon in the vertebral body stent (vbs), the surgeon noticed no pressure build up was possible.The stent did not expand and could not be removed from the vertebral body.The stent remained in the patient and could be fixed with vertecem cement as indicated.Inflating the balloon outside the patient showed the balloon leaked fluid.Close examination could not show a tear in the balloon, but it is clearly not functional.The surgery was completed with injection of cement around the stent.No second stent was used nor could the not-expanded stent be retrieved.It is now safely enclosed with cement.The surgery was successfully completed.The surgery was not prolonged.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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

No harm to the patient.Surgery was completed successfully.

Manufacturer Narrative

Manufacturing evaluation was completed.The delivery system of the complaint instrument was returned without the stent.The review of the manufacturing history of the production lot did not reveal any nonconformity considered being relevant considering the complaint.The complained instrument was manufactured per specifications and successfully passed all in-process inspections as well as the final inspection, including a leakage test.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 be built up; at about 2-3 atm the balloon opened and a fine water jet became apparent.Microscopic inspection of the balloon revealed a pinhole with longitudinal orientation.Several scratches and surface abrasions were observed on the balloon surface in close vicinity to the pinhole.Based on these findings it seems likely that the most probable root cause for the complaint event is related to external factors during the procedure (e.G.Balloon damage due to sharp solid bone fragments).No manufacturing related issue was identified.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

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

Concomitant devices reported: access kit ( part number unknown, lot number unknown, quantity unknown); inflation system (part number unknown, lot number unknown, quantity unknown).

• Brand Name: VBS MEDIUM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6696893
• MDR Text Key: 79529620
• Report Number: 3000270450-2017-10233
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 09.804.501S
• Device Lot Number: 0117020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention