MAUDE Adverse Event Report: MSD DEGGENDORF MFG SOVEREIGN SPINAL SYSTEM

Catalog Number 7968212INT

Device Problem Crack (1135)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product code: ovd - intervertebral fusion device with integrated fixation, lumbar this part is not approved for use in the united states; however a like device catalog # 7968212, 510k #k091813 and upn (b)(4) was approved for sale in the united states.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that the patient underwent an unspecified surgery at l5-s1 due to spondylolisthesis.Intra-operatively, the cage cracked during final tightening.The cage was then removed and replaced with another one of the same dimension without any problem.There was no fragment of the device remaining inside the patient.No patient complications were reported as a result of the event.

Manufacturer Narrative

Product analysis: the sovereign spacer was returned with a crack running from the upper side of the screw hole 180 degrees.There were witness marks located under the shelf of the screw hole.This indicates that the screw was placed too deep either from force or misalignment.Once the screw gets under the shelf it will start to place pressure outwardly on the implant leading to the implant cracking to relieve the stress.Product image review: submitted images appear to display cracked interbody spacer.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: 7062542
• MDR Text Key: 93310766
• Report Number: 1030489-2017-02396
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: 7968212INT
• Device Lot Number: 204755275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 02/13/2018
• Supplement Dates FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2011
• 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
• Patient Age: 51 YR