MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for INFERIOR 2/3 ORBIT - LEFT - 10 9567 manufactured by Stryker Orthobiologics-malvern.
[32747648]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[32747649]
It is reported by claimant attorney that patient was implanted with a medpor-related device (exact implant not specified) during a maxillectomy in (b)(6) 2009. The area surrounding the implant developed an infection and claimant had to undergo a two-step revision, having the device removed and antibiotic spacers placed in (b)(6) 2015, and having new hardware implanted in (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[54426963]
The reported event could be confirmed according to the medical records received. For infection reports expanded investigations were performed to assure that neither the device nor all related manufacturing (e. G. Environmental monitoring, sterilization validations tests) process steps (and beyond that) could have caused or contributed to the reported event. Within the expanded investigations no indication was found for any systematic, design or manufacturing related issue. Based on quality sign off product was sterilized per specification. Therefore the infection is not related to the porex device. For this case the received records were reviewed by a consulting surgeon who specializes in facs, cmf surgery and reconstructive surgery. The patient underwent a radical leftsided total maxillectomy. The porex implant has been fixed with synthes fixation screws to replace the resected maxillary bone. On post-operative ct scan it is illustrated that the screws have not been placed within stable craniofacial skeleton but within muscle and surrounding tissue. The surgeon? S inadequate placement of screws contributed to micromotion and inevitable failure of the reconstruction surgery from the very beginning. In addition, to line the maxillary sinus cavity an avascular segment of cadaver skin allograft (? Dermatrix? ? Non-stryker) was used. This tissue block of cellular dermis is intended to be placed on top of a healthy bed of vascular tissue capable of supplying vascular ingrowth. Cadaver dermis is a common nidus for infection when placed within contaminated sinus cavities, unless it? S securely sutured and fashioned onto a bed of healthy, robust tissue for immediate neo-angiogenesis and durable vasculation. The surgeon? S inadequate placement contributed to micromotion and inevitable failure of the reconstruction surgery from the very beginning. As cited in the ifu, for proper placement use at least four (4) points of fixation for cranial implants. Use stryker universal neuro fixation systems and take care to use appropriate screw length to avoid penetrating the dura. For cranial implants fixated directly to bone through the implant, position screws with at least 4mm of material overlap to patient bone. And medpor implants should not be used in areas of recent or active infection until the surgeon has determined that the infection has been completely eradicated.
Patient Sequence No: 1, Text Type: N, H10
[54426964]
It is reported by claimant attorney that patient was implanted with a medpor-related device (exact implant not specified) during a maxillectomy in (b)(6) 2009. The area surrounding the implant developed an infection and claimant had to undergo a two-step revision, having the device removed and antibiotic spacers placed in (b)(6) 2015, and having new hardware implanted in (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
[68388761]
Supplemental (b)(4) was already filed, outlining the investigation results, and this was solely to update the product number as that had not been previously filed.
Patient Sequence No: 1, Text Type: N, H10
[68388762]
It is reported by claimant attorney that patient was implanted with a medpor-related device (exact implant not specified) during a maxillectomy in (b)(6) 2009. The area surrounding the implant developed an infection and claimant had to undergo a two-step revision, having the device removed and antibiotic spacers placed in (b)(6) 2015, and having new hardware implanted in (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2015-00318 |
| MDR Report Key | 5268419 |
| Date Received | 2015-12-04 |
| Date of Report | 2017-02-17 |
| Date of Event | 2009-12-01 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 2008-03-06 |
| Date Added to Maude | 2015-12-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KELLI DYKSTRA |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Street | 45 GREAT VALLEY PARKWAY |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFERIOR 2/3 ORBIT - LEFT - 10 |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-12-04 |
| Catalog Number | 9567 |
| Lot Number | D282B01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ORTHOBIOLOGICS-MALVERN |
| Manufacturer Address | 45 GREAT VALLEY PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-04 |