MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Malposition of Device (2616)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

Devices of multiple part/lot numbers were implanted during the procedure including: part: 55740008550/ lot: unk (x1) part: 55740007540/ lot: unk (x1) part: 55740006540/ lot: unk (x1) although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes.These parts are not approved for sale in the us but a similar part with catalogue's: 55840008550, 55840007540 and 55740006540; 510k# k113174 and udi# (b)(4) respectively is approved for sale in the us.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.

Event Description

It was reported that on (b)(6) 2017, patient presented with pre-op diagnosis as: degenerative lumbar scoliosis.For which, patient underwent posterior lumbar interbody fusion (plif) procedure.Post-op, when patient awoke from anesthesia, it was confirmed that the left leg did not have smooth movement.Ct was taken for confirmation and it revealed that there was no event such as implants touching nerves etc.However, the l2 left screw deviated to lateral side, the screw was in the vertebral body (in-out-in technique).Patient issue has not been resolved.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON® SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6517696
• MDR Text Key: 73558596
• Report Number: 1030489-2017-00980
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: REFER 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: 03/31/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 03/31/2017
• Supplement Dates FDA Received: 10/03/2017
• 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 Age: 67 YR