MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-21 for HELIPLUG 62202 manufactured by Integra York, Pa Inc.
[20003951]
Customer initially reports that two pts had tooth extractions and developed infections. Physician reporting because lots are part of the recall notice received from integra. (b)(6) 2013: doctor reports the following: pt (b)(6), on (b)(6) 2013: pt presented with complaint of swelling upper right. Exam shows fractured root (mb) #3, endo treated and periodontal abscess. Diagnosis: non-restorable. Treatment: extract, graft for bone preservation and implant. Pt deferred extraction that day for personal reason. Amox antibiotic for short term relief. (b)(6) 2013: schedule for extraction. Surgical extraction via split root tech and root extraction to conserve buccal plate and reflex tissue. Straumann allograft ocan, helioplug over bone, cytoflex resorb for closure. Close with 3 x 3 silk suture. One week follow-up for suture removal. (b)(6) 2013: pt complains of pain and bad taste from area. Dr out of office, at meetings. Staff called with pt's complaint to: advise x-ray (viewed remotely) antibiotic (amox 875 bid x 7 days) and return on doctor's time back in office. (b)(6) 2013: exudate in site. Debride, irrigate and another round of amox. (b)(6) 2013: healing within normal limits.
Patient Sequence No: 1, Text Type: D, B5
[20166493]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00024 |
| MDR Report Key | 3129828 |
| Report Source | 05 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-05-21 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-05-28 |
| 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 | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIPLUG |
| Generic Name | NA |
| Product Code | LPG |
| Date Received | 2013-05-21 |
| Catalog Number | 62202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-21 |