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

Catalog Number SEE H10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The following products were used in the surgery dated (b)(6) 2019: product id: 7967210, lot: unknown, 510(k): k091813, udi: (b)(4).Product id: 7975520, lot: 0711932w, 510(k): k110063, udi: (b)(4).Product id: 4986840, lot: h5453664, 510(k): k133205, udi: (b)(4).Product id: 4986040, lot: h5469189, 510(k): k133205, udi: (b)(4).Product id: 4986040, lot: h5466195, 510(k): k133205, udi: (b)(4).Product id: 4986040, lot: h5430748, 510(k): k133205, udi: (b)(4).Although it is unknown whether the above products (that were used for anterior fixation) caused or contributed to the reported event, we are filling this mdr for notification purposes.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with adjacent segmental disease; and underwent oblique lumbar interbody fusion 25 and oblique lumbar interbody fusion 51.The procedure was finished as planned and there were no complications.On (b)(6) 2019, for the purpose of clinical trials, the patient underwent posterior fixation with xia serrato, manufactured by (b)(4) stryker.It was said that during this operation, major bleeding occurred when thoracic spine osteotomy was being performed, and blood transfusion of about 8 units was performed.It was reported that the patient's left leg could not move at this point after implants from another manufacturer were used for posterior fixation.Also, reportedly, on (b)(6) 2019, after the operation, the doctor removed the blood tumor from the posterior side.The causal relationship with the reported implants that were used for anterior fixation could not be confirmed.

• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 9490392
• MDR Text Key: 180788556
• Report Number: 1030489-2019-01440
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 38