CAPSTONE CONTROL¿ SPINAL SYSTEM
Report
- Report Number
- 1030489-2021-01046
- Event Type
- Malfunction
- Date Received
- August 16, 2021
- Date of Event
- July 21, 2021
- Report Date
- January 6, 2022
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- LXH
- PMA / PMN Number
- K120368
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H3: PRODUCT ANALYSIS: PART #3990004, LOT #99 VISUAL AND OPTICAL INSPECTION CONFIRMED THE KNOB OF THE THREADED INSERTER HAS BEEN SHEARED OFF. THE INSERTER IS THREADED INTO THE GR ASPING INSERTER. UNABLE TO REMOVE THE INSERTER SINCE THE KNOB HAS BEEN SHEARED OFF. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR L5 SP ONDYLOLYTIC SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE INNER CYLINDER OF THE INSERTER BROKE WHILE THE CAGE WAS BEING INSERTED. THE PART OF THE HEAD TO BE GRIPPED AND THE SHAFT ARE SEPARATED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE IMPLANT COULD NOT BE REMOVED DUE TO DAMAGE TO THE INSERTER SHAFT. THERE IS NO MALFUNCTION WITH THE IMPLANT ITSELF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE DIAL WAS DAMAGED DURING IMPLANTING WHEN INSERTING THE FIRST CAGE INTO L5 / S. THE CAGE WAS IMPLANTED LATERALLY ACCORDING TO SURGICAL TECHNIQUE AND WAS DAMAGED NEAR THE ENTRANCE TO THE INTERVERTEBRAL SPACE. SINCE THE CAGE COULD NOT BE REMOVED, BOTH THE IMPLANT AND THE INSTRUMENT WERE CHANGED. THE IMPLANT COULD NOT BE REMOVED DUE TO DAMAGE TO THE INSERTER SHAFT. ALL THE REPORTED PRODUCTS ARE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1226186 | CAPSTONE CONTROL¿ SPINAL SYSTEM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK USA, INC | 3990004 | 99 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |