MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-02 for MEMBRAGEL 070-101 manufactured by Institut Straumann Ag.
[20093268]
Implantation of a dental implant was carried out on (b)(6), 2011 in regio 23 with concurrent augmentation using bone ceramic 070. 204 lot z0666 and membragel 070. 101 al077. Dafalgan, (b)(6) and doxyline were prescribed. Clinician reports on (b)(6), 2011 there was a dehiscence above the implant. The membragel was swollen and exposed. The membrane was shortened and newly sutured. On (b)(6), 2012 there was a vestibular suture dehiscence. (b)(6) were used. On (b)(6), 2011 it is reported that it was better but there was still an opening. (b)(6) used. On (b)(6), 2011 there was an apical dehiscence in region 24. (b)(6) used. On (b)(6), 2011 there was an apical suture dehiscence 1mm in diameter in region 24. The bone/membragel were visible. Pt reports pain. The sutures were explanted in 10 days. On (b)(6), 2011, the wound had healed but the edges were still red. (b)(6) prescribed. Removal of the sutures. On (b)(6), 2011 the implant in region 23 was uncovered. There was buccal swelling. A release incision was made. The bone ceramic and membragel were removed.
Patient Sequence No: 1, Text Type: D, B5
[20275864]
Catalog# 070. 101, membragel, package insert instructions for use state "treatment outcome is dependent on operative technique and pt response. As with any surgical procedure, infection is a risk. Use sterile intra-operative technique. Do not use at infection sites. " catalog# 070. 101, membragel, package insert instructions for use state "the following complications are common with the surgical intervention with barrier membranes and therefore may not be totally excluded: soft tissue dehiscence, hematoma, pain, inflammation, increased sensitivity and redness. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222315-2012-00006 |
| MDR Report Key | 2644347 |
| Report Source | 01,05 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-29 |
| Date of Event | 2011-09-08 |
| Date Added to Maude | 2012-07-10 |
| 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 | MEMBRAGEL |
| Generic Name | BARRIER MEMBRANE |
| Product Code | NPK |
| Date Received | 2012-07-02 |
| Model Number | 070-101 |
| Lot Number | AL077 |
| Device Expiration Date | 2012-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT STRAUMANN AG |
| Manufacturer Address | BASEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-02 |