ALAMO T
Report
- Report Number
- 3008520015-2016-00001
- Event Type
- Malfunction
- Date Received
- January 12, 2017
- Date of Event
- March 17, 2016
- Report Date
- May 17, 2016
- Manufacturer
- ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE)
- Product Code
- MAX
- UDI-DI
- M6863211I0091
- PMA / PMN Number
- K140303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ALAMO C IMPLANT (PART # 3211I-009) CONTINUES TO BE NOT AVAILABLE; DEVICE REMAINS IMPLANTED IN PATIENT. PRODUCT EVALUATION CONDUCTED ON ALAMO T CURVED INSERTER THAT WAS USED IN THE SURGERY (PART # 2811T-1005; LOT # 3711T). EVALUATION INCLUDED: ANALYSIS OF MATING CONNECTION BETWEEN IMPLANT (PART # 3211I-009) AND CURVED INSERTER (PART # 2811T-1005); AND PERFORMANCE TESTING USING RETURNED ALAMO T CURVED INSERTER (PART #2811T-1005; LOT # 3711TI) AND 3 ALAMO T IMPLANTS FROM SAME LOT USED IN SURGERY (PART # 3211I-009; LOT # SM56681) IN AN ATTEMPT TO RE-CREATE REPORTED "PREMATURE DETACHMENT OF THE CAGE" FAILURE. PERFORMANCE TESTING CONSISTED OF 3 INDIVIDUALS APPLYING 10 AXIAL HEAVY STRIKES AND 10 OBLIQUE LEVERAGING STRIKES TO INSERTER CONNECTED TO IMPLANT HELD IN A VISE. RESULTS WERE AS FOLLOWS: MATING CONNECTION BETWEEN IMPLANT AND INSERTER MET DIMENSIONAL SPECIFICATIONS; AND ALL IMPLANTS REMAINED CONNECTED TO INSERTER AFTER IMPACTION TEST. BASED ON EVALUATION, FAILURE MODE COULD NOT BE RE-CREATED (NOT CONFIRMED), AND THREAD MATING CONNECTION DESIGN BETWEEN IMPLANT AND INSERTER IS ACCEPTABLE. PER FIELD REP CONVERSATION WITH DOCTOR, PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SECOND SUPPLEMENTAL REPORT WILL BE FILED.
THE 9 MM ALAMO T INTERVERTEBRAL BODY FUSION DEVICE THAT IS INVOLVED IN THE EVENT, PART # 3211I-009 LOT # SM56681 (CLASS II DEVICE), WAS RECEIVED FROM THE CONTRACTED MANUFACTURER AS PART OF A LOT QUANTITY OF (B)(4) ON 4/28/2014. THE LOT WAS INSPECTED TO ANSI/ASQ Z1.4-1993 GENERAL LEVEL II 1.0 AQL SAMPLING PLAN WITH NO NON-CONFORMANCES AND RELEASED TO INVENTORY. THE IMPLANT IS NOT AVAILABLE FOR EVALUATION BECAUSE THE DEVICE REMAINS IMPLANTED IN THE PATIENT (PER FIELD REPRESENTATIVE, DOCTOR DETERMINED IMPLANT COULD NOT BE RETRIEVED DUE TO PATIENT SAFETY). CONFIRMED, HOWEVER, VIA X-RAY IMAGING THAT THE IMPLANT (PART # 3211I-009; LOT # SM56681) IS MALPOSITIONED. THE ALAMO T CURVED INSERTER THAT WAS USED IN THE SURGERY (PART # 2811T-1005; LOT # 3711T), HOWEVER, WAS RETURNED ON 4/13/2016 AND IS CURRENTLY UNDERGOING PRODUCT EVALUATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED CONTAINING THE RESULTS OF THE PRODUCT EVALUATION. SHOULD THE DOCTOR DECIDE TO TAKE FURTHER ACTION AND THE DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION BE OBTAINED, IT WILL BE INCLUDED IN THAT SUPPLEMENTAL REPORT.
IT WAS REPORTED DURING LUMBAR SURGERY AT L4-5 ON PATIENT, UPON PLACEMENT OF THE LUMBAR CAGE FROM ALLIANCE SPINE, DOCTOR EXPERIENCED PREMATURE DETACHMENT OF THE CAGE. CONSEQUENTLY, THE CAGE MIGRATED AWAY FROM THE INTERVERTEBRAL SPACE AND LODGED ITSELF INTO THE LEFT PSOAS MUSCLE. NOW, THE PATIENT PRESENTS WITH LIMITED FLEXION OF THE LEFT THIGH.
IT WAS REPORTED DURING LUMBAR SURGERY AT L4-5 ON PATIENT, UPON PLACEMENT OF THE LUMBAR CAGE FROM ALLIANCE SPINE, DOCTOR EXPERIENCED PREMATURE DETACHMENT OF THE CAGE. CONSEQUENTLY, THE CAGE MIGRATED AWAY FROM THE INTERVERTEBRAL SPACE AND LODGED ITSELF INTO THE LEFT PSOAS MUSCLE. NOW, THE PATIENT PRESENTS WITH LIMITED FLEXION OF THE LEFT THIGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30219 | ALAMO T | INTERVERTEBRAL BODY FUSION DEVICE | MAX | ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE) | 3211I-009 | SM56681 | M6863211I0091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |