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 2018-06-19 for BONE GRAFTING MATERIAL, SYNTHETIC manufactured by Oberdorf Synthes Produktions Gmbh.
[111542851]
There are multiple patients. All information is provided in the literature article. There are multiple unknown dates of event subsequent to (b)(6) 2011. This report is for an unknown chronos bone void filler wedge /unknown lot. Part and lot numbers are unknown; udi number is unknown. There are multiple dates of implantation (b)(6) and (b)(6) 2012. It is unknown if or when devices were explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter phone number is unknown. 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, the investigation will be updated as applicable. 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
[111542852]
This report is being filed after the review of the following journal article: jung, wh. Et al (2014), efficacy of periarticular multimodal drug injection after medial opening-wedge high tibial osteotomy: a randomized, controlled study, arthroscopy: the journal of arthroscopic and related surgery, vol. 30 no. 10, pages 1261-1268 (korea) the purpose of this prospective study was to evaluate the efficacy of periarticular multimodal drug injection after medial opening-wedge high tibial osteotomy (mowhto) regarding the postoperative pain level. Between january 2011 and january 2012, 35 patients (3 male and 32 female) with a mean age of 60. 4 ranging 37 to 80 years from group i and 35 patients (2 male and 33 female) with a mean age of 58. 8 ranging from 43 to 71 years from group ii underwent medial opening-wedge high tibial osteotomy for symptomatic medial compartment osteoarthritis using tomofix plate (synthes, (b)(4)). These 70 knees (70 patients) were randomly assigned to 1 of 2 groups. A porous b-tricalcium phosphate wedge (semicircular chronos; synthes) was inserted into the osteotomy gap. Range-of-motion exercises with continuous passive motion were continued until a maximum flexion angle of 130 or more was obtained within 3 weeks of surgery. Patients were allowing to begin partial weight-bearing exercises with crutches or a walker 1 day after surgery, and they could walk with full weight bearing with cane 6 weeks after mowhto. Vas score ranging from 0 (no pain) to 10 (worst imaginable pain). When patients complained of persistent pain with a visual analog scale (vas) score greater than 3, 75 mg of diclofenac sodium was injected intravenously until a vas score of less than 3 was achieved. However, an additional 50 mg of tramadol hydrochloride was injected if the vas score was greater than 3 with initial injection of 75 mg of diclofenac sodium. The primary outcome variables were pain levels at 6 hours, 12 hours, 18 hours, 1 day, 4 days, 7 days, and 14 days postoperatively. The following complications were reported: the highest pain level in group i occurred at 6 hours postoperatively and gradually diminished with time. The mean vas score of this group at 6 hours postoperatively was 6. 5 +/- 1. 9 (range, 3 to 10). The highest pain level in group ii occurred at 12 hours postoperatively and gradually diminished with time. This report is for an unknown synthes chronos bone void filler wedge. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-54425 |
| MDR Report Key | 7614859 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-19 |
| Date of Report | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-06-19 |
| 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 | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2018-06-19 |
| 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 | 2018-06-19 |