MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-08 for SILICONE PIP SZ. 1 SPIP-520-1-WW manufactured by Ascension Orthopedics.
[153798929]
Dhr - review of manufacturing records for spip-520-1-ww cmr 163711t showed no evidence of a nonconformance that may have caused or contributed to the reported event. Failure analysis - the device in question has not been returned to date. Images of the explanted spip were provided showing the device in two pieces, separated at the hinge, confirming the reported event. Root cause - 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
[153798930]
On (b)(6) 2017 a silicone pip (id spip-520-1-ww - silicone pip sz. 1) was implanted due to a bouchard's node with pain. During a regular follow-up visit on (b)(6) 2019, the patient complained that the finger had become difficult to extend and on (b)(6) 2019 the implant was removed by revision surgery due to an early fracture of the hinge. There is no information about other traumatic events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2019-00029 |
| MDR Report Key | 8875563 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-08 |
| Date of Report | 2019-07-16 |
| Date Mfgr Received | 2019-07-16 |
| Date Added to Maude | 2019-08-08 |
| 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 |
| 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. 1 |
| Generic Name | SILICONE PIP |
| Product Code | KYJ |
| Date Received | 2019-08-08 |
| Catalog Number | SPIP-520-1-WW |
| Lot Number | 163711T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-08-08 |