MAUDE Adverse Event Report: MSD DEGGENDORF MFG SOVEREIGN SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 7968212

Device Problem Crack (1135)

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

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) (b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

It was reported that patient underwent alif at l5- s1 with preoperative diagnosis of stenosis.Intra-op, during placing a fixed angle screw, the implant developed a small crack.Two additional fixed angle screws and a cover placed were placed.The implant was used in the patient.No patient complications were reported.

• Brand Name: SOVEREIGN SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MSD DEGGENDORF MFG; wertstrasse 17; deggendorf 94469
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5272950
• MDR Text Key: 33363077
• Report Number: 1030489-2015-03336
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2018
• Device Catalogue Number: 7968212
• Device Lot Number: 204097171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2010
• 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