WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.527 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
|
Back to Search Results |
|
Model Number SD800.527 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 09/14/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part number: sd800.527.Lot number: 316p868.Supplier lot number: n/a.Manufacture date or release to warehouse date: 07/28/2021.Expiration date: n/a.Supplier/manufacture site: (b)(4).No ncrs were generated during production of lot number 316p868.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that on (b)(6) 2021, a patient developed an infection, and a new patient specific implant (psi) has been requested.The patient had implants on (b)(6) 2021.The implant was removed (b)(6) 2021, due to infection.It was unknown if the removal surgery completed successfully.The patient outcome was fine.This complaint involves an unknown number of devices.This report is for (1) psi sd800.527 peek implant.This report is 1 of 15 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|