MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-01-22 for LAMINA ELEVATOR 388.170 manufactured by Synthes Tuttlingen.
[36686148]
Patient initials are (b)(6). Patient weight is unknown. Device is an instrument and is not implanted or explanted. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. A review of the device history records has been requested and is currently pending completion. Device 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.
Patient Sequence No: 1, Text Type: N, H10
[36686149]
It was reported that a patient underwent an open door laminoplasty procedure from c3 to c7 on (b)(6) 2016. After the surgeon scored the contralateral side of the lamina at c6 for graft placement, the lamina elevator was inserted. It was noted that the surgeon used excessive force during use of lamina elevator. The surgeon performed more scoring and again inserted the lamina elevator at which time a piece of the elevator broke off into the patient. The piece was easily retrieved. Another lamina elevator was available for use to complete the procedure. There was no reported patient harm; the procedure was extended by approximately one (1) minute. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[37747931]
Device history record review: manufacturing date: february 4, 2011. Review of the device history records showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. All parts were checked for function at the final inspection. The raw material, which was delivered as lot bo79970 for the handles, is corresponding to the specifications. No non-conformance reports were generated during production. Device 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.
Patient Sequence No: 1, Text Type: N, H10
[39572780]
Device was used for treatment, not diagnosis. A product development investigation was performed for the subject device (lamina elevator, part number 388. 170, lot number t953217). The subject device was returned with the complaint that the device broke after the? Surgeon used excessive force? Resulting in a fragment that was easily retrieved. The lamina elevator (388. 170) is noted in the arch fixation system to be utilized for open door laminoplasty procedures and is specifically utilized for laminar expansion after the laminectomy has been completed. The lamina elevator is placed under the ventral surface of the completely transected lamina and the opposite set of tines is centered on the hinged lamina. The gap can be expanded by firmly grasping the lamina so that trialing can take place per the technique guide. The returned instrument was examined and the complaint condition was able to be confirmed as the holding mechanism spring was found to be missing. The remained of the instrument operated as intended and was found to be without identifiable defect or deficiency. Per the complaint description a root cause related to the application of excessive force can be established. The relevant drawings for the subject device were reviewed. The design, materials and finishing processes were found to be appropriate for the intended use of the device. A device history review was performed for the returned instrument lot number as previously reported and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition (as previously reported). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-10410 |
| MDR Report Key | 5386337 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-08 |
| Date of Event | 2016-01-08 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2011-02-04 |
| Date Added to Maude | 2016-01-22 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINA ELEVATOR |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2016-01-22 |
| Returned To Mfg | 2016-01-21 |
| Catalog Number | 388.170 |
| Lot Number | T953217 |
| ID Number | (01)10705034772141(10)T953217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-22 |