T2 STRATOSPHERE
Report
- Report Number
- 1030489-2020-00758
- Event Type
- Injury
- Date Received
- July 1, 2020
- Date of Event
- June 16, 2020
- Report Date
- November 27, 2020
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- MQP
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
H3: PRODUCT ANALYSIS: PART # 436120C, LOT # CA19C075, VISUAL OPTICAL FUNCTIONAL VISUAL AND OPTICAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE TEETH OF THE CAGE. THE BODY SET SCREW WAS TIGHTENED ALL THE WAY DOWN. FUNCTIONAL TEST WITH A SAMPLE INSERTER CONFIRMED THE CENTERPIECE WOULD NOT OPEN SMOOTHLY AND COLLAPSE. PER THE PRINT (B)(6) ON NOTE 7 REV-C, WITH THE LOCKING SET SCREW BACKED OUT, THE ASSEMBLY MUST BE ABLE TO SMOOTHLY EXPAND AND COLLAPSE. THE IMPLANT APPEARS TO BE RESTRICTED FROM DEBRIS IN BETWEEN THE BODY AND INNER PIECE OF THE IMPLANT. UNABLE TO DETERMINE ROOT CAUSE OF ISSUE. 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.
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.
THE REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2020. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
PMA/510K: K183510. REPORT SOURCE: (B)(6). PRODUCT EVENT SUMMARY#: PRE-OP DIAGNOSIS: L2 VERTEBRAL BODY FRACTURE, PROCEDURE INVOLVED: KYPHOPLASTY LEVELS IMPLANTED: L2. IMPLANT DATE: (B)(6) 2020. PRODUCT RETURN STATUS: IMPLANTED: REMAINED IN PATIENT IT WAS REPORTED THAT ON (B)(6) 2020, POST-OP, THE IMPLANT BACKED OUT AND THE ADJUSTABLE END CAP MOVED AFTER LOCKING. REVISION SURGERY IS SCHEDULED TO BE PERFORMED ON (B)(6) 2020 IN WHICH THE POSTERIOR FIXATION WILL BE PERFORMED AND THE CAGE ON THE ANTERIOR SIDE WILL BE PLACED AGAIN. IN THIS CASE POSTERIOR SPINAL FUSION WAS NOT YET PERFORMED. DURING THE OPERATION FOR CAGE PLACING, THE SURGEON WANTED TO KEEP THE LORDOSIS LEVEL. THE ANGLE OF THE END CAP WAS FIXED BEFORE LENGTHENING THE CAGE, AND THE CAGE WAS PLACED BY PRESSING WITH HAND. THE SALES REP CONSIDERED THAT THE CAGE WAS LENGTHENED WAS QUITE LARGER THAN MEASURED ONE AT THAT TIME, SO THE ANTERIOR LONGITUDINAL LIGAMENT MIGHT ALSO BE DAMAGED. RE-OPERATION IS SCHEDULED FOR TOMORROW ((B)(6)). IT IS PLANNED TO PERFORM THE ANTERIOR SPINAL FUSION AGAIN AFTER THE POSTERIOR SPINAL FIXATION. THE SALES REP. ONLY RECEIVED A CALL FROM THE SURGEON AND DETAILS WILL BE CONFIRMED LATER ON (B)(6) 2020. DOCTOR¿S COMMENTS: THE ANGLE OF THE END CAP MAY HAVE CHANGED. UPDATE RECEIVED ON 18 JUN 2020: PATIENT DEMOGRAPHICS: GENDER- FEMALE, AGE (AT THE TIME OF EVENT)- 75 YEAR PRODUCT RETURN STATUS: EXPLANTED CAGE MIGRATION HAD BEEN OBSERVED 7 DAYS AFTER SURGERY. IN THE DOCTOR'S OPINION, THERE WAS A HIGH POSSIBILITY THAT AN END PLATE WAS FRACTURED AT THE TIME OF CAGE LENGTHENING DURING INITIAL OPERATION, WHICH CAUSES THE EVENT. IN THE REOPERATION, THE CAGE ON THE ANTERIOR SIDE WAS REMOVED AFTER THE POSTERIOR FIXATION, AND THE T3 CAGE OF SAME SIZE WAS UNPACKED AND REINSERTED, AND THE OPERATION WAS FINISHED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM HCP VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH L2 VERTEBRAL BODY FRACTURE FOR SPINAL THERAPY. PROCEDURE INVOLVED: KYPHOPLASTY LEVELS IMPLANTED: L2. IMPLANT DATE: (B)(6) 2020. PRODUCT RETURN STATUS: IMPLANTED, REMAINED IN PATIENT IT WAS REPORTED , POST-OP, THE IMPLANT BACKED OUT AND THE ADJUSTABLE END CAP MOVED AFTER LOCKING. REVISION SURGERY IS SCHEDULED TO BE PERFORMED ON (B)(6) 2020 IN WHICH THE POSTERIOR FIXATION WILL BE PERFORMED AND THE CAGE ON THE ANTERIOR SIDE WILL BE PLACED AGAIN. IN THIS CASE POSTERIOR SPINAL FUSION WAS NOT YET PERFORMED. DURING THE OPERATION FOR CAGE PLACING, THE SURGEON WANTED TO KEEP THE LORDOSIS LEVEL. THE ANGLE OF THE END CAP WAS FIXED BEFORE LENGTHENING THE CAGE, AND THE CAGE WAS PLACED BY PRESSING WITH HAND. THE SALES REP CONSIDERED THAT THE CAGE WAS LENGTHENED WAS QUITE LARGER THAN MEASURED ONE AT THAT TIME, SO THE ANTERIOR LONGITUDINAL LIGAMENT MIGHT ALSO BE DAMAGED. RE-OPERATION IS SCHEDULED FOR TOMORROW ((B)(6)). IT IS PLANNED TO PERFORM THE ANTERIOR SPINAL FUSION AGAIN AFTER THE POSTERIOR SPINAL FIXATION. THE SALES REP. ONLY RECEIVED A CALL FROM THE SURGEON AND DETAILS WILL BE CONFIRMED LATER ON (B)(6) 2020. DOCTOR¿S COMMENTS: THE ANGLE OF THE END CAP MAY HAVE CHANGED. UPDATE RECEIVED ON 18 JUN 2020: PATIENT DEMOGRAPHICS: GENDER- FEMALE, AGE (AT THE TIME OF EVENT)- 75 YEAR PRODUCT RETURN STATUS: EXPLANTED; DISCARDED CAGE MIGRATION HAD BEEN OBSERVED 7 DAYS AFTER SURGERY. IN THE DOCTOR'S OPINION, THERE WAS A HIGH POSSIBILITY THAT AN END PLATE WAS FRACTURED AT THE TIME OF CAGE LENGTHENING DURING INITIAL OPERATION, WHICH CAUSES THE EVENT. IN THE REOPERATION, THE CAGE ON THE ANTERIOR SIDE WAS REMOVED AFTER THE POSTERIOR FIXATION, AND THE T3 CAGE OF SAME SIZE WAS UNPACKED AND REINSERTED, AND THE OPERATION WAS FINISHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 684934 | T2 STRATOSPHERE | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | MQP | MEDTRONIC SOFAMOR DANEK USA, INC | 436120C | CA19C075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |