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 2018-06-04 for SILICONE PIP SZ. 2 SPIP-520-2-WW manufactured by Ascension Orthopedics.
[109996538]
The product was not returned for evaluation. Review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event. Based on the information received to date, the root cause is undetermined. The event may be due to trauma or an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[109996542]
It was reported that a spip-520-2-ww silicone pip implant showed signs of tear and breakage. On (b)(6) 2016, an athrodesis of the pipj was performed with a spip-520-2-ww silicone pip implant. However, 2 years post implantation, the implant showed signs of tear and breakage with signs of lateral shift. No specific trauma or contributing events prior to the discovery of the issue. Subsequently, the implanted product was explanted on (b)(6) 2018 and was replaced with another of the same size. No further patient complications were reported and the patient was doing well after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00028 |
| MDR Report Key | 7566856 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-04 |
| Date of Report | 2018-05-23 |
| Date Mfgr Received | 2018-05-23 |
| Date Added to Maude | 2018-06-04 |
| 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 | DENTAL HYGIENIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE PIP SZ. 2 |
| Generic Name | SILICONE PIP |
| Product Code | KYJ |
| Date Received | 2018-06-04 |
| Catalog Number | SPIP-520-2-WW |
| Lot Number | 161334T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-04 |