MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-20 for MEDPOR CUSTOMIZED MIDFACE 54440510 manufactured by Stryker Orthobiologics-malvern.
[5518752]
During a company representatives visit at the (b)(6), it was mentioned that postoperatively an infection occurred, affecting a patient who received two medpor customized midface implants which were implanted on (b)(6) 2014. Additional information was received stating the infection developed on both sides. As of (b)(6) 2014 the devices were still in situ. The decision to remove one or both implants and determine if further treatment is required is pending.
Patient Sequence No: 1, Text Type: D, B5
[12793280]
The device is still implanted in the patient. If additional information becomes available or the device is sent back, a supplemental report will be filed. Device still implanted.
Patient Sequence No: 1, Text Type: N, H10
[32686175]
Although the device was not returned for investigation, the reported event could be confirmed based on the provided bacteriological report. On inquiry stryker received the report of the bacteriology from the related university hospital, which was reviewed and evaluated by stryker cmf? S clinical expert. The report shows that all of the analyzed germs originated from the oral cavity. The clinical expert reasoned that the patient? S germs caused the infection primarily. Most likely the abscess germs were intraoperatively introduced from the oral cavity. Summarizing the investigation the root cause of the determined failure mode can be tied to a patient / user related issue. Indications for any material or design related issues were not determined in the investigation.
Patient Sequence No: 1, Text Type: N, H10
[32686176]
During a company representatives visit at the (b)(6), it was mentioned that postoperatively an infection occurred, affecting a patient who received two medpor customized midface implants which were implanted on (b)(6) 2014. Additional information was received stating the infection developed on both sides. As of (b)(6) 2014 the devices were still in situ. The decision to remove one or both implants and determine if further treatment is required is pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2015-00032 |
| MDR Report Key | 4532792 |
| Report Source | 05 |
| Date Received | 2015-02-20 |
| Date of Report | 2014-10-01 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2015-02-12 |
| Device Manufacturer Date | 2013-12-30 |
| Date Added to Maude | 2015-02-20 |
| 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. JULIE SCHOELL |
| 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 | MEDPOR CUSTOMIZED MIDFACE |
| Generic Name | IMPLANT |
| Product Code | FWP |
| Date Received | 2015-02-20 |
| Catalog Number | 54440510 |
| Lot Number | K09428LF26MAY (LEFT SIDE) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-02-20 |