MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-20 for PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE manufactured by Oberdorf Synthes Produktions Gmbh.
[111836816]
There are multiple patients. All known information is presented in the literature article. 510k: this report is for an unknown synpor 0. 8mm porous polyethylene coated titanium mesh/unknown lot. Part and lot numbers are unknown; udi number is unknown. There are multiple unknown dates of implantation march 2011 to may 2016. It is unknown if or when devices were explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Code (b)(4) used to capture diplopia, mild enophthalmos, and limitation of ocular motility. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[111836817]
This report is being filed after the review of the following journal article. Kim y. C. Et al (2018) patient-specific puzzle implant preformed with 3d-printed rapid prototype model for combined orbital floor and medial wall fracture. Journal of plastic, reconstructive and aesthetic surgery. Volume 71. Pages 496-503. (korea, south) this study was done to propose surgical strategies using customized three-dimensional (3d) puzzle implants preformed with rapid prototype (rp) skull model. Between march 2011 to may 2016, a total of 28 patients (24 males and 4 females, with a mean age of 35. 36 years) underwent reconstructive surgery. All patients were implanted with an unknown 0. 8mm synthes porous polyethylene coated titanium mesh to cover the bone defect area. The patients were divided into the comminuted inferomedial strut group (15 patients) and intact inferomedial strut group (13 patients) based on the inferomedial strut involvement. The mean follow-up period was 11. 54 (range, 6-20) months. Clinical findings, including enophthalmos, visual acuity, and presence of diplopia, were assessed preoperatively and postoperatively at the 1- and 6-month follow-ups. Enophthalmos was defined as the posterior displacement of the affected eye relative to the unaffected side by measuring the difference between each side. The evaluation scale consisted of three categories as follows: mild enophthalmos (range, 0? 1 mm); moderate enophthalmos (range, 1? 2 mm); and severe enophthalmos (>2 mm). The presence of diplopia was assessed in all gaze positions. Ocular motility was assessed in four positions of gaze (adduction, abduction, supraduction, and infraduction) and was graded on a scale of -1 to -4 (-1, duction of 30?? 45? ; -2, duction of 15?? 30? ; -3, duction of <15? ; and -4, no movement). These complications represent the patients under the comminuted inferomedial strut group: four (4) patients presented with diplopia 1 month postoperatively, then decreased to just one patient six months after which improved at 1 year postoperatively. One (1) patient presented with mild enophthalmos up until 6 months postoperatively, which eventually decreased during the long-term follow-up. One (1) patient presented with limitation of ocular motility at -1 (position of gaze), but showed improvement within the normal range at 1 year postoperatively. These complications represent the patients under the intact inferomedial strut group: three patients presented with diplopia 1 month postoperatively. This report is for an unknown synthes 0. 8mm porous polyethylene coated titanium mesh this report is 1 of 1 for (b)(4). A copy of the literature article is being submitted with this medwatch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-54437 |
| MDR Report Key | 7619731 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-20 |
| Date of Report | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-06-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE |
| Product Code | GWO |
| Date Received | 2018-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-20 |