MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-24 for UNK - WASHERS manufactured by Oberdorf Synthes Produktions Gmbh.
[188489990]
There are multiple patients all information is provided in the article. This report is for an unknown washer/unknown lot. Part and lot number are unknown; udi number is unknown. 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. (b)(4). 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
[188489991]
This report is being filed after the review of the following journal article: tonetti, j. Et al (2003), iliosacral screw placement with ultrasound-based navigation versus conventional fluoroscopy, techniques in orthopaedics, vol. 18 (2), pages 184-190, doi: 10. 1097/00013611-200306000-00007 (france). The aim of this study is to propose a ct-based navigation, using for the first time an ultrasound-based registration and clinical results are documented and compared with previous series of patients who underwent traditional fluoroscopic percutaneous surgery. A total of 34 patients were included in the study. Surgery was performed by percutaneous fluoroscopic screwing in 30 patients (23 male and 7 female) with an average age of 34. 7 years (range, 17-60 y) using a cannulated screw ancillary (mathys inc, etupe, france). 4 patients (1 male and 3 female) with an average age of 48. 5 years (range, 34? 71 y) were instrumented with a cas using a 6. 5-mm diameter screw for cancellous bones with 32-mm long threading and a washer (mathys inc. , etupe, france). The follow up of the patients included radiographic evaluation at 3 months. The following complications were reported as follows: fluoroscopic group: 1 patient died. 18 patients had postoperative neurologic deficit (7 patients with lesions of the lumbosacral trunk, 5 patients with s1 root lesions, 6 patients with cauda equina lesions). 4 patients had peripheral action antalgic drugs, 7 patients with minor central antalgic, and 1 patient with major central antalgic. The postoperative ct scan control data of the fluoroscopic group found 12 misplaced screws. In 8 patients, the misplaced screws were on the anterior side. In 3 patients, the misplaced screws were crossing the s1 root foramen. In one patient, the wrong placement was both anterior and foraminal. In 4 cases, the screws were too short with negative? C? Values. 3 patients had loosening of the implanted screws. Cas group: 1 patient took central minor antalgic drugs. A (b)(6)-year-old patient with poor mineralize bone had loosening of the implants. This report is for an unknown synthes cannulated screws, unknown synthes cancellous screws, and unknown synthes washers. This report is for one (1) unknown washer. This is report 2 of 2 for (b)(4). This complaint is linked to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02196 |
| MDR Report Key | 9871429 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-24 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT 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 |
| Brand Name | UNK - WASHERS |
| Generic Name | BOLT, NUT, WAHSER |
| Product Code | HTN |
| Date Received | 2020-03-24 |
| 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 | 2020-03-24 |