MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 7078397

Device Problems Metal Shedding Debris (1804); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent a posterior spinal surgical procedure at t12-l5 to treat degenerative scoliosis.It was reported that during insertion of the set screw in the bone screw, debris came off of the set screw.No patient complications were reported.

Manufacturer Narrative

(b)(4).This part is not approved for use in the united states; however a like device catalog # 5440030, 510k # k102555 was cleared in the united states.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Manufacturer Narrative

Additional info: visual and microscopic analysis revealed the coating on the trailing side of the screw's threads appears to be damaged/coating pealed off.This kind of damage can occur if there is pressure place on the screw as it is being tighten down (the rod not fully reduce in screw head).Functionally the screw had no problem going into a sample screw head.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3802377
• MDR Text Key: 4477357
• Report Number: 1030489-2014-02453
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

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: 10/04/2021
• Device Catalogue Number: 7078397
• Device Lot Number: H13J3881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 05/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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
• Treatment: BONE SCREW