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

Catalog Number 7078396

Device Problem Metal Shedding Debris (1804)

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

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).This part is not approved for use in the united states; however a like device catalog # 5540030, 510k # (b)(4) 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.

Event Description

It was reported that patient underwent posterior fusion at th10-s2ai.During surgery, burrs came off while inserting the set screw into the mas screw due to cross-threading and set screw was replaced.Patient complications are reported unknown.

Manufacturer Narrative

Product analysis:visual and microscopic examination of the returned set screw identified the upper flanks of the set screw surface is skived, starting at the start of the thread, with a thin portion of the upper flank removed.This damage is consistent with overloading the set screw thread due to incomplete seating of the rod in the mas saddle.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5331379
• MDR Text Key: 35037515
• Report Number: 1030489-2015-03583
• Device Sequence Number: 1
• Product Code: NKB
• 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,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Catalogue Number: 7078396
• Device Lot Number: H5164179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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