MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INFLATION SYSTEM-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 03.804.413S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown synflate/vbs/unknown lot.Part and lot numbers are unknown; udi number is unknown.Additional product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.Possible 510k:#.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, that a balloon-based vertebral augmentation system was performed.During the procedure, the surgeon was inflating the balloon, the surgeon had noted no inflation of the balloon at 30 atmosphere (atm) on a computed arm despite the balloon being confirmed as functional and contrast media visible.The surgeon decided to carry on increasing the pressure using the inflation device.Inflation of balloon was noted and on continuing with inflation the device made a loud cracking noise.Subsequently, continued inflation wasn¿t possible.The sales consultant suggests to the surgeon that the breakage of the inflation device was due to the fact the maximum recommended pressure had been far exceeded.The procedure was completed without any delay.There was no impact to the patient.Concomitant device reported: biopsy kit 10 g ( 03.804.522s, lot# unknown, quantity 1) this complaint involves one (1) device this report is 1 of 1 for pc-(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

Thhis report is for one (1) inflation system-sterile.Concomitant medical products: biopsy kit 10 g (03.804.522s, lot# unknown, quantity 1), synflate vertebral balloon ( 03.804.701s, lot# 0417089, quantity 1).

Manufacturer Narrative

Device history records review was completed for part: 03.804.413s, lot: 8022618.Manufacturing location: (b)(4), release to warehouse date: jun 06, 2018, expiry date: feb 01, 2023.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The certificate of conformity was reviewed and it confirms that the material of the product did met inspection records, certification test values, and acceptance criteria.Finally the review has shown that there were no issues during the manufacture of this product which would contribute to this complaint condition.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: INFLATION SYSTEM-STERILE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8115569
• MDR Text Key: 128796051
• Report Number: 8030965-2018-58567
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• PMA/PMN Number: K110604
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: 03.804.413S
• Device Lot Number: 8022618
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2019
• Patient Sequence Number: 1