MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CAPSTONE CONTROL PTC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 5001022

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Neuropathy (1983)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a cage for a cage replacement.It was reported that rt10mm inserted in l3/4 backed out.It was removed, and pc12mm was inserted.Treatment or additional surgery was performed as a result of this event and the cage was replaced.The cage was removed.A sized up cage was inserted.The cage backed out.The levels implanted were l3/4.The pre-op diagnosis was kyphosis.The therapy used was that the cage was removed and it was replaced with a sized up one.The patient experienced radicular symptoms as a result of the event.Patient did not achieve solid fusion as the cage was inserted on (b)(6) 2020.It is unknown if the patient issue has been resolved.There was health damage.The product was replaced by a medtronic product.No further complications were reported/ anticipated.

• Brand Name: CAPSTONE CONTROL PTC
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 10395033
• MDR Text Key: 202502782
• Report Number: 1030489-2020-01077
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5001022
• Device Catalogue Number: 5001022
• Device Lot Number: H5503462
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention