MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA. INC CAPSTONE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 2991226

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

It was reported that during an unspecified spinal surgery while removing the inserter after implanting the cage, debris fell out with the instrument.The cage still remains in patient¿s spine.No patient injuries were reported.

Manufacturer Narrative

(b)(4): the device was not returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.

Manufacturer Narrative

Additional information: product was returned.Visual and microscopic examination identified a ~3mm portion of the top face of the implant, which interfaces directly with the inserter.Microscopic examination of the returned portion of the implant identified a brittle fracture with rays emanating from the top corner of the implant, consistent with overload.Additionally the threaded hole found the threads stripped, consistent with excessive force during attempted implantation.

Manufacturer Narrative

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

• Brand Name: CAPSTONE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA. INC; 1800 pyramid place; memphis TN 38132
• 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: 4578381
• MDR Text Key: 5561564
• Report Number: 1030489-2015-00468
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2991226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• 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
• Treatment: INSERTER
• Patient Age: 00056 YR