MAUDE Adverse Event Report: SYNTHES GMBH IN-SPACE - INTERSPINOUS IMPLANT SIZ 14 P

Catalog Number 04.630.014S

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the wings of the implant are not working, the in-space spacer does not open.This is report 1 of 1 for this event (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.510k#: device is not distributed in the united states, but is similar to device marketed in the usa a review of the device history records was performed and no complaint related issues were found.The visual inspection of the returned device by the complaint handling unit revealed all four wings of the peek implant are still un-deployed.Additionally circular marks are clearly visible on the connecting end of the implant.The review of the manufacturing documents revealed that the implant was manufactured in april 2013 according to the specifications.No manufacturing related conditions were found.The complaint condition is likely the result of the implant not attached correctly onto the implant holder (the slots of the implant did not match with the tappets of the implant holder), resulting in a wrong orientation of the implant and finally preventing the deployment of the wings as the wings were covered by the wall of the sleeve.No product fault could be detected.Placeholder.

• Brand Name: IN-SPACE - INTERSPINOUS IMPLANT SIZ 14 P
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3640343
• MDR Text Key: 4281910
• Report Number: 8030965-2014-00370
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 04.630.014S
• Device Lot Number: AA2626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 57 YR