MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL manufactured by Oberdorf Synthes Produktions Gmbh.
[108895620]
There are multiple patients. All known information is detailed in the article. Event dates are multiple unknown dates between 2005 and 2012. This report is for an unknown synthes arch laminoplasty system and unknown synthes screws /unknown lot. Part and lot numbers are unknown; udi number is unknown. There are multiple unknown dates of implantation. It is unknown if or when devices were explanted. Complainant part is not expected to be returned for manufacturer review/investigation. There are multiple unknown concomitant therapy dates between 2005 and august 2011. Reporter postal code and phone number are 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
[108895621]
This report is being filed after the review of the following journal article: tung, kl. Et al (2015), single-door cervical laminoplasty using titanium miniplates alone, journal of orthopaedic surgery, vol. 23 no. 2, pages 174-179 ((b)(6)). The purpose of this study is to review the records for the outcome of 29 patients (20 men and 9 women) who underwent surgery between 2005 and 2012. Surgery included single-door cervical laminoplasty for myelopathy using titanium miniplates for treatment of cervical spondylotic myelopathy, ossification of the posterior longitudinal ligament and central cord system. Patient ages ranged 35 to 79 years. Prior to august 2011, 19 patients were implanted with a non-synthes 20-hole titanium miniplate; after august 2011, 10 patients were implanted with an unknown depuy synthes pre-contoured arch laminoplasty system. The mean follow-up was 4 years, ranging 2-9 years. Postoperatively, a soft neck collar was worn for 2 weeks with neck mobilization exercises permitted as pain improved. The authors did not specify if the complications experienced were involving patients implanted with non-synthes miniplates or the arch system. Therefore, all complications will be reported as follows for the arch system: hinge non-unions in 2 of the unplated laminae. Spring back closure occurred in 5 of the unplated laminae, with a mean of <3 mm loss of the initial expansion. Transient c5 palsy developed, presenting as shoulder abduction weakness in 2 patients. Delayed dural tear due to sharp spike at the edge of the opened c6 lamina in 1 patient. 2 screw pullouts (not associated with plate loosening). Concomitant devices: non-synthes 20-hole titanium miniplate (part number: unknown, lot number: unknown, quantity: unknown). This report is for an unknown synthes arch laminoplasty system and unknown synthes screws. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53824 |
| MDR Report Key | 7525147 |
| Date Received | 2018-05-18 |
| Date of Report | 2018-04-25 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-18 |
| 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 | 0 |
| Generic Name | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY METAL |
| Product Code | NQW |
| Date Received | 2018-05-18 |
| 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 | 2018-05-18 |