MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-04-11 for TRIAL IMPLANT LARGE-6MM 03.820.046 manufactured by Synthes Tuttlingen.
[4418587]
It was reported the patient was diagnosed with a herniated disc at c4-c5 and underwent a total disc replacement with prodisc-c. During the procedure, the small piece in the trial implant stop fell off into the patient. The little piece caused the instrument to advance too far. The surgeon noticed and pulled the trial out and retrieved the little piece that fell off. There was no reported adverse event or delay. The patient is reportedly doing fine. On an unknown date in 2008, the patient also had a previous prodisc-c surgery by the same surgeon which is still implanted. The patient experienced a herniated disk at an adjacent level c5-c6 and underwent a total disc replacement with prodisc-c. There was no allegation of deficiency against the implant noted. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11837416]
(b)(6). Device is an instrument and is not implanted / explanted. The review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw materials which were delivered are corresponding to the specifications. There were no ncrs generated during production. 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
[12150289]
Device was used for treatment, not diagnosis. Additional narrative: a manufacturing evaluation was performed. The investigation of the complaint articles has shown that the 03. 820. 046 is one trial (17mm w x 14mm d x 6mm h) in the family of pro-disc c trials. The trials connect to the 03. 820. 000 trial handle which allow the surgeon to determine the proper height, width, and depth of the pro-disc c implant. The trialing steps of the pro-disc c procedure can be found in the technique guide j7501-e. The trial has a threaded design feature which allows the surgeon to advance the trial body deeper into the disc space to ensure proper posterior placement of the implant. The initial step prior to trialing is to rotate the trial handle/trial clockwise to get the trial to the most anterior placement. Each counterclockwise rotation advances the trial 0. 5mm posterior. Per the complaint description, the device lost the clip which was retrieved by the surgeon. The clip is laser welded per 03_820_045 rev h which is sufficient for the design feature as the clip interface shouldn't experience loading which would push out the clip and cause the laser weld to fail. The liberated clip was not returned. The chu engineer reviewed engineering drawings and the materials and specifications are adequate for the device's intended use. 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
[12820727]
Additional narrative: a manufacturing investigation was conducted. The report indicates that there were no issues during the manufacture of the product that would contribute to this complaint condition. Considering the clip was secured with 4 laser points, too much force causing it to fell off. (b)(4). A pd evaluation was conducted. The report indicates that the 03. 820. 046 is one trial (17mm w x 14mm d x 6mm h) in the family of pro-disc c trials. The trials connect to the 03. 820. 000 trial handle which allow the surgeon to determine the proper height, width, and depth of the pro-disc c implant. The trialing steps of the pro-disc c procedure can be found in the technique guide j7501-e. The trial has a threaded design feature which allows the surgeon to advance the trial body deeper into the disc space to ensure proper posterior placement of the implant. The initial step prior to trialing is to rotate the trial handle/trial clockwise to get the trial to the most anterior placement. Each counterclockwise rotation advances the trial 0. 5mm posterior. Per the complaint description, the device lost the clip which was retrieved by the surgeon. The clip is laser welded per 03_820_045 rev h which is sufficient for the design feature as the clip interface shouldn't experience loading which would push out the clip and cause the laser weld to fail. The liberated clip was not returned. The chu engineer reviewed engineering drawings and the materials and specifications are adequate for the device's intended use. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680938-2014-10013 |
| MDR Report Key | 3745746 |
| Report Source | 05,07 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-25 |
| Date of Event | 2014-03-25 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2007-12-18 |
| Date Added to Maude | 2014-06-06 |
| 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 | 0 |
| Event Location | 0 |
| 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 | TRIAL IMPLANT LARGE-6MM |
| Generic Name | TEMPLATE |
| Product Code | EML |
| Date Received | 2014-04-11 |
| Returned To Mfg | 2014-04-08 |
| Catalog Number | 03.820.046 |
| Lot Number | A7QA50 |
| 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 | 2014-04-11 |