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 2016-08-22 for TM-S - 14X14X7MM, ANGLED N/A 06-101-03071 manufactured by Zimmer Tmt.
[52719114]
Investigation in process.
Patient Sequence No: 1, Text Type: N, H10
[52719115]
Sales rep (b)(6) reported a revision. Dr (b)(6) will be removing a tm-s device from a year out. The tm-s device was implanted (via acdf) at c5-c6 and has healed. Following the initially surgery, the patient developed a herniated disc at c3-c4 and stenosis at c6-c7. The patient was revised to address the new issues and a corpectomy was performed.
Patient Sequence No: 1, Text Type: D, B5
[58948270]
On (b)(6) 2016, complaint (b)(4) was reported by the sales representative , concerning a tm-s implant with the dimensions of 14x14x7mm (part no. 06-101-03071, lot no. 62998472). The implantation surgery occurred in (b)(6), on (b)(6) 2016. The subject device was implanted between cervical vertebrae c5-c6 as part of an anterior cervical discectomy and fusion (acdf) procedure with the use of mergence-s instruments. There were no complications in the implant surgery, nor was there any harm to the patient. It was noted the healed fusion of the cervical vertebrae c5-c6 three months after the tm-s implantation. In the same time, a herniated disc between cervical vertebrae c3-c4 and stenosis between cervical vertebrae c6-c7 had developed post-surgery. The acdf procedure was revised only in an effort to address the herniated disc and stenosis between cervical vertebrae c3-c4 and c6-c7, respectively. In the revision surgery, the tm-s device was removed and a vbr-s device was implanted into the patient. No issue relating to the design or function of the tm-s implant was reported. No action is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[58948271]
It was reported that a revision will be performed to remove a tm-s device from a year out. The tm-s device was implanted (via acdf) at c5-c6 and has healed. Following the initial surgery, the patient developed a herniated disc at c3-c4 and stenosis at c6-c7. The patient was revised to address the new issues and a corpectomy was performed
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005751028-2016-00065 |
| MDR Report Key | 5894384 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-22 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2015-04-09 |
| Date Added to Maude | 2016-08-22 |
| 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 | MR. WILLIAM HARA |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Manufacturer G1 | ZIMMER TMT |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM-S - 14X14X7MM, ANGLED |
| Generic Name | TM-S |
| Product Code | OBP |
| Date Received | 2016-08-22 |
| Model Number | N/A |
| Catalog Number | 06-101-03071 |
| Lot Number | 62998472 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-22 |