MAUDE Adverse Event Report: SYNTHES BETTLACH SYNCAGE-LR 45º/90º WIDE 12*28*38 PEEK; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.881S

Device Problem Component Missing (2306)

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

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.Device not reportedly explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review ¿ manufacturing location: (b)(4).Manufacturing date: 28.May 2009 expiry date: 01.May 2019.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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.

Event Description

Device report from synthes eu reports an event in (b)(6) as follows: after the implantation of a peek cage in lwk 4/5, there was no tantum marker in the ap and lateral x-ray, so neither device could be identified.The implant insertion holder would not hold during implantation, thus the peek cage had to be inserted free-hand using the cage positioning aid.The exact location of the implants could not be confirmed.There was reportedly 20 minutes surgical delay.This is report 1 of 2 for (b)(4).

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5035197
• MDR Text Key: 24290850
• Report Number: 9612488-2015-10437
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 889.881S
• Device Lot Number: 2484061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1