MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-07-15 for STRAUMANN BONE CERAMIC 070.204 manufactured by Inst Straumann, Ag.
[18618461]
Clinician reports approx 6 weeks after a bone block transplant treatment using mebragel and straumann bone ceramic abscesses appeared. The clinician noted that it appeared to be healing but now the abcesses are returning. Augmentation with autologic bone (micross) and bone ceramic. On (b)(6) 2011 clinician identified to straumann that the product involved is article 070. 101, membragel, 0. 8 ml, lot y0113 and article 070. 204, straumann bone ceramic, 0. 5-1. 0mm, 0. 5g, lot y0113. On (b)(6) 2010 swelling and fistula observed. Infection treated with dalacin and chc.
Patient Sequence No: 1, Text Type: D, B5
[18740459]
Review of lot y0113 batch record indicate that the product was released according to specs. A review of the mfr product complaint database show that no further complaints where infection (fistula, abscesses) have been reported, have been received by the mfr with lot number y0113. Clinician supplied add'l info concerning event provided to mfr on 6/20/2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2011-00031 |
| MDR Report Key | 2169516 |
| Report Source | 01,05 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-07-15 |
| Date of Event | 2010-12-20 |
| Date Mfgr Received | 2011-06-20 |
| Date Added to Maude | 2011-07-22 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BERNIE MCDONALD |
| Manufacturer Street | 60 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787472514 |
| Manufacturer G1 | BIORA AB |
| Manufacturer Street | MEDON SCIENCE PARK |
| Manufacturer City | MALMO |
| Manufacturer Country | SW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRAUMANN BONE CERAMIC |
| Generic Name | SYNTHETIC BONE GRAFTING MATERIAL |
| Product Code | NPK |
| Date Received | 2011-07-15 |
| Catalog Number | 070.204 |
| Lot Number | Y0113 |
| Device Expiration Date | 2011-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INST STRAUMANN, AG |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-15 |