MAUDE Adverse Event Report: MSD DEGGENDORF MFG SOVEREIGN SPINAL SYSTEM

Catalog Number 7969814INT

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Common device name: intervertebral fusion device with integrated fixation, lumbar.Two lots of the suspect device was identified, however it is unknown which one is the complaint product.The lots that were used lot 203784839; lot 204283935.This device is not approved for sale in us but a similar device with product id: 7969814, (b)(4) and 510k number k091813 is approved for sale in us.Neither the device nor applicable imaging devices were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

It was reported that patient with degenerative disc disease underwent anterior lumbar interbody fusion.Intra-op, when screwing the last of three screws, the cage was split.The cage could not be removed.No patient complications were reported as a result of this event.

Manufacturer Narrative

Image review: "by report, l4-5 sovereign interbody graft split during screw insertion.A single x-ray is provided, i do not see the hardware failure in this image.Graft placement used size appears appropriate." if information is provided in the future, a supplemental report will be issued.

• Brand Name: SOVEREIGN SPINAL SYSTEM
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6776322
• MDR Text Key: 82122439
• Report Number: 1030489-2017-01885
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: SEE H10
• 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
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Catalogue Number: 7969814INT
• Device Lot Number: 208847508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCREWS
• Patient Age: 40 YR
• Patient Weight: 94