MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 7578302

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

The product is not returned to manufacturer for evaluation.

Event Description

Pre-op diagnosis: lumbar posterior decompression fusion procedure: posterior fusion levels: l2 to iliac excluding l4 it was reported that intra-op, an extender that was attached to a screw at left il (starting point was medial il) interfered with a "cl" connector for 20mm length and could not be removed after final tightening of the screw.The extender interfered with the driver.So the surgeon tried to remove the extender first, but the surgeon could not because the extender got stuck between the connector and the screw head although it showed ej on it.The surgeon removed the extender forcibly so tip of extender was broken and the tip was pulled up forcibly with pliers.These implantations at il to s were mostly performed via an open approach.The product broke.No fragments of product remained inside the patient.There was a delay of less than 60 minutes because of the aforementioned problem.No patient complications were reported.

Manufacturer Narrative

Product analysis: visually and optically confirmed the broken off instrument component is cracked and bent outward, consistent with bend stress overload.The above observations are consistent with bend stress overload as the mechanism of failure.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5629658
• MDR Text Key: 44337357
• Report Number: 1030489-2016-01290
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122862
• 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: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7578302
• Device Lot Number: EM13F022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1