OBERDORF SYNTHES PRODUKTIONS GMBH CRANIAL-SCR PLUSDRIVE 1.6 SELF-DRILL L3; SCREW,FIXATION,BONE
|
Back to Search Results |
|
Catalog Number 400.833.04S |
Device Problem
Difficult to Advance (2920)
|
Patient Problems
Failure of Implant (1924); No Code Available (3191)
|
Event Date 08/04/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the proper insertion of 3mm screws was not possible.The screws were rejected and 4mm screws were used instead.Concomitant device: unk - screws: trauma (part# unknown, lot# unknown, quantity unknown).This report is for one (1) cranial-scr plusdrive ø1.6 self-drill l3.This is report 1 of 2 for (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.H3, h4, h6- 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.A dhr review could not be performed for this pi.No record for this lot number could be located.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.
|
|
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.D4: lot number reported as either 61p1044 or 61p5824.H6: part: 400.833.04s, lot: 61p1044, manufacturing site: bettlach, release to warehouse date: july 07, 2020, expiry date: june 01, 2030.A manufacturing record evaluation was performed for the finished device part: 400.833.04s , lot: 61p1044, and no non-conformances were identified.Part: 400.833.04s, lot: 61p5824, manufacturing site: bettlach, release to warehouse date: july 10, 2020, expiry date: july 01, 2030.A manufacturing record evaluation was performed for the finished device part: 400.833.04s, lot: 61p5824, 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.
|
|
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.H3, h6: part:400.833.04s, lot:61p1044, manufacturing site: bettlach, release to warehouse date: july 07, 2020, expiry date: june 01, 2030.A manufacturing record evaluation was performed for the finished device part: 400.833.04s , lot: 61p1044, 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.
|
|
Search Alerts/Recalls
|
|
|