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 2020-03-11 for ACTIV L PE-INLAY 8.5MM SW965 manufactured by Aesculap Ag.
[183100731]
Manufacturing site evaluation: no product at hand. The investigation was performed by exponent. Investigation: the articulating surface of the polyethylene inserts had evidence of machining marks and multidirectional scratches. All three components had evidence of damage consistent with impingement. Overall the results of the stage i analysis are consistent with devices having a short implantation time, iatrogenic damage, and impingement. Stage iii analysis was conducted to assess the condition of the polyethylene insert. Stage iii analysis found a low oxidation level of the insert (oi < 1) 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 (e. G. , low = 0-4; moderate = 5-8; high = 9-10)2; however, comparing these values to campbell, 2010 is limited because the original scoring system is not intended for use in the spine. Batch history review: because the batch of the pe- inlay (sw965) is further on unknown, a batch history review is not possible. The manufacturing documents of the other components (sw981k / sw986k) has been checked and found to be according to specification valid during the time of production. There are no further complaints with the known lots at hand. Conclusion and root cause: the root cause for the problem is most probably usage and / or patient related. Rationale: because there is 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 too strong by the user, design layout unsuitable, inadequate patient behaviour, the investigation at "exponent" did not reveal any relevant product deviations. A material defect or manufacturing error can be excluded. Corrective action: according to (b)(4) there is no capa necessary.
Patient Sequence No: 1, Text Type: N, H10
[183100732]
It was reported that there was an issue with an activ l pe-inlay. According to the reporter there has been a postoperative incident. Reason for revision: patient complained of pain in facet joints. Surgeon tried multiple joint injections, with pain subsiding but then returned. A revision surgery was necessary and scheduled for (b)(6) 2018. It was noted that the patient was very arthritic. Additional information was not provided nor available. The adverse event is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2019-00931 ((b)(4) sw981k), 9610612-2019-00932 ((b)(4) sw986k).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2020-00050 |
| MDR Report Key | 9820130 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-11 |
| 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 PE-INLAY 8.5MM |
| Generic Name | IMPLANTS SPINAL MOTION |
| Product Code | MJO |
| Date Received | 2020-03-11 |
| Model Number | SW965 |
| Catalog Number | SW965 |
| 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 | 2020-03-11 |