SYNTHES GMBH CUSTOM-MADE DEVICE TRUMATCH CMF PEEK MIL; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
|
Back to Search Results |
|
Catalog Number SD802.835 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: this report is for an unknown psi implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 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
|
Device report from synthes reports an event in germany as follows: it was reported on an unknown date that the customer is reporting a cmf-cranioplastie to be too large frontally, so there was too much space after implantation.This report is for one (1) unk - psi implants.This is report 1 of 1 for complaint (b)(4).
|
|
Event Description
|
This is report 1 of 2 for pc-(b)(4).
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: updated total number of reports forthis pc.D1: device name added.D4: udi added; catalog number added.G1: manufacture site added.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H4: manufacture date added.H3, h4, h6: investigation summary 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: sd802.835, lot#: 898p168, manufacturing site: mezzovico, release to warehouse date: 22 jun 2022, a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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.D4: updated data for lot number.
|
|
Search Alerts/Recalls
|
|
|