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

Catalog Number 5440030

Device Problem Metal Shedding Debris (1804)

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

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

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 an unknown date in 2012, the patient underwent a spinal fusion surgery at l3-5, with the help of pedicle screws.Post-operatively, due to degenerative disc disease and central stenosis, patient underwent revision surgery (posterior spinal fusion), extending fusion from l2 to l5.During this surgery, while implanting set screw at right-side l5 level, the surgeon experienced shearing.Three different set screws sheared off metal fragments when surgeon was trying to place them during provisional tightening.A final set screw was used successfully after the surgeon backed out the pedicle screw a bit.Metal shards from the set screws were visible inside the patients wound and had to be evacuated by the surgeon and his assistant.Reportedly, the problem was caused as the interface between the 4.75 pedicle screw head and the set screw was causing the metal fragments to shear off of the set screw.The pedicle screw remained implanted in the patient.There were no patient complications reported.

Manufacturer Narrative

Product analysis: visual and optical examination of the top flank of the initial thread identified deformation and thread shearing, consistent with significant pre-load prior to final tightening.The above observations are consistent incomplete seating of the rod in the bone screw saddle prior to tightening of the set screw.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao,pr TN 00792
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6032980
• MDR Text Key: 57558362
• Report Number: 1030489-2016-02910
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5440030
• Device Lot Number: H5274328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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