MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-29 for ACTIV L SUP.PLATE SIZE M 6?/SPIKES SW981K manufactured by Aesculap Ag.
[176991058]
General information: preliminary investigation - batch history review: because the lot number is unknown, a batch history review is not possible. Conclusion and root cause: due to the circumstances we do not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure. Rationale: because there are no products and only minor information available, a definitive root cause analysis is not possible. Following causes are possible: wrong system configuration selected by the user, wrong implant size chosen by the user, end plate formed to strong by the user, design layout unsuitable, inadequate patient behaviour. According to sa-de13-m-4-2-04-000-0 there is no capa necessary. Summary of exponent (third party) evaluation: retrieval analysis- components were received and sterilized; identified as 2 endplates and 1 polyethylene inlay. Lot numbers were as follows: superior endplate - 52165757, inferior endplate 5181291, and inlay unknown. Surface assessment: both endplates showed signs of iatrogenic damage. The backside surface of endplates had remnants of bone; all 3 components had evidence of impingement. Mating marks consistent with impingement were observed. Matching marks and multidirectional scratches were observed on the articulating and backside surfaces of the inlay, and the inlay was discolored. Dimensional analysis: the differences between the drawing measurements and the retrieved inlay was measured to be within the manufacturing tolerance per aesculap drawing. Summary and conclusions: stage i through iii analysis was completed for the retrieved devices. The articulating surface of the inserts had evidence of matching marks and multidirectional scratches. All 3 components had evidence of damage consistent with impingement. Overall the results of the stage i analysis are consistent with devices having short implantation time, iatrogenic damage, and impingement. Stage iii analysis was conducted to assess the condition of the insert; a low oxidation level of the insert and mechanical properties consistent with this level of oxidation. Histology analysis demonstrated tissues composed of fibrous tissue and bone. Birefringent and metal particles were observed. One sample showed evidence of implant material that may have fragmented off the device during retrieval. Alval scores ranged from 2 to 6 for all tissues evaluated. The alval score would generally be considered low to moderate when compared with tissues from hip patients demonstrating device-material related tissue reaction; however, comparing these lvalues to campbell, 2010 is limited because the original scoring system is not intended for use in the spine.
Patient Sequence No: 1, Text Type: N, H10
[176991059]
It was reported that there was an issue with activ l plate. Following information was reported: the patient was originally implanted on (b)(6) 2016 at l5/s1; the primary diagnoses had been stenosis. Surgeon attempted multiple joint injections, with pain subsiding but then returned. The reason for revision was due to patient complaints of pain in facet joints. The patient activity level had been reported as "moderate". On (b)(6) 2018, the surgical site description was noted as normal and healthy, without signs of debris or osteolysis. The endplates were "normal". Device was removed using aesculap removal instruments and osteotomes. No complications occurred during removal. The device looked "good" according to surgeon. There was some damage to activl implants during removal when using osteotomes. Revision treatment: fusion. The adverse event is filed under (b)(4). Associated medwatch-reports: 9610612-2019-00932 ((b)(4) sw986k).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00931 |
| MDR Report Key | 9643021 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-29 |
| Date of Report | 2020-03-13 |
| Date of Event | 2018-07-19 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIV L SUP.PLATE SIZE M 6?/SPIKES |
| Generic Name | SPINAL MOTION |
| Product Code | MJO |
| Date Received | 2020-01-29 |
| Model Number | SW981K |
| Catalog Number | SW981K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-29 |