MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2010-10-14 for MEDPOR 89020 manufactured by Porex Surgical.
[1471269]
The doctor stated that the pt received a medpor frontal cranial implant. The doctor reported that the pt developed a shunt infection that lead to the removal of the implant. The doctor stated that there was no issue with the implant and the pt is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[8857108]
The device history records for lot number 89020-mci-115-09 (b)(4) was reviewed and all processing and test criteria are within the mepdor implant specification.
Patient Sequence No: 1, Text Type: N, H10
[17393024]
As reported by the (b)(6) registry, approximately a month post index procedure, the patient was diagnosed with an ischemic stroke. Eight months post-procedure, the patient expired. The cause of death is unknown. The patient is a an (b)(6) female who was enrolled in the (b)(6) study for stenting of the ostium of the right internal carotid artery. The index procedure took place on (b)(6) 2009. The rate of stenosis is 86%. An angioguard (601814rmc / lot 70209537) distal protection device was deployed distal in the vessel and the lesion was pre-dilated. A precise (pc0730rxc/ lot 14003079) stent was deployed in the lesion. There was no malfunction with the stent. The angioguard was successfully retrieved. There were no complications during the procedure. The patient was discharged three days later. Approximately one month post index procedure, the patient experienced hemiparesis on the left side. Onset was gradual. Diagnosis was a stroke. The event was evaluated and determined to be unrelated to the index procedure and unrelated to the cordis product. Approximately eight months post procedure, the patient expired. The cause of death is unknown. The event was evaluated and determined to be unrelated to the index procedure and unrelated to the cordis product.
Patient Sequence No: 1, Text Type: D, B5
[17751574]
The doctor reported that the patient received a medpor customized implant that did not conform well to the temporal regions of the skull. The doctor stated that he tried to mold/trim but the post op appearance was not that pleasant. The doctor stated that there is a large step off between the lateral edges and the cranium bi temporally. Device not returned
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1057129-2010-00037 |
| MDR Report Key | 1878330 |
| Report Source | *,05 |
| Date Received | 2010-10-14 |
| Date of Report | 2010-10-14 |
| Date Mfgr Received | 2010-09-29 |
| Device Manufacturer Date | 2009-03-28 |
| Date Added to Maude | 2011-01-28 |
| 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 | MR. KENT IVERSEN |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 302651017 |
| Manufacturer Country | US |
| Manufacturer Postal | 302651017 |
| Manufacturer Phone | 6784791611 |
| Manufacturer G1 | POREX SURGICAL |
| Manufacturer Street | 15 DART ROAD |
| Manufacturer City | NEWNAN GA 30265101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30265 1017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDPOR |
| Generic Name | MEDPOR CUSTOMIZED SURGICAL IMPLANT |
| Product Code | JOF |
| Date Received | 2010-10-14 |
| Model Number | NA |
| Catalog Number | 89020 |
| Lot Number | MCI-11509 E015C33H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POREX SURGICAL |
| Manufacturer Address | NEWMAN GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-14 |