MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-10-04 for DAUTREY ARCH BAR, 15CM 01-02960 manufactured by Stryker Leibinger Freiburg.
[16218158]
The customer complained that the arch bar has edges. It pulls or tears gums. The rail is very edgy and it is feared that it can hurt the patient. The customer had to top the items off, regrind them and bend them before use which caused a delay of 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[16425974]
Investigation in progress but not yet complete.
Patient Sequence No: 1, Text Type: N, H10
[31146732]
The reported event could be confirmed. Visual inspection revealed that the edges of the current arch bars are very sharp. However, within functional inspection the reported event could not be reproduced. Also a comparison with the current drawing has shown that the products meet the specification. To address the customer concerns a change request was initiated on 2014-mar-10 to redesign the arch bar in a way it gets smoother. As a part of the redesign the edges will be new defined (rounded off) and the pegs more curved. The change request is still ongoing.
Patient Sequence No: 1, Text Type: N, H10
[31146733]
The customer complained that the arch bar has edges. It pulls or tears gums. The rail is very edgy and it is feared that it can hurt the patient. The customer had to top the items off, regrind them and bend them before use which caused a delay of 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2013-00251 |
| MDR Report Key | 3388261 |
| Report Source | 05 |
| Date Received | 2013-10-04 |
| Date of Report | 2013-09-11 |
| Date of Event | 2013-09-10 |
| Date Mfgr Received | 2013-09-11 |
| Device Manufacturer Date | 2012-12-04 |
| Date Added to Maude | 2014-01-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JAMSHED BADARPURA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAUTREY ARCH BAR, 15CM |
| Generic Name | INSTRUMENT |
| Product Code | EHO |
| Date Received | 2013-10-04 |
| Returned To Mfg | 2013-09-19 |
| Catalog Number | 01-02960 |
| Lot Number | 6000008879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-04 |