MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-05-06 for SURGICAL MESH manufactured by Synthes Usa.
[44589799]
Device was used for treatment, not diagnosis. Stulik (2007): total spondylectomy of c2: a new surgical technique. Acta chirurgiae orthopaedicae et traumatologiae cechosl. , 74, 2007, p. 79? 90. This report is for an unknown synmesh titan cage/unknown quantity/unknown lot. Udi # unknown part number, udi is unavailable. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. 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
[44589800]
This report is being filed after the subsequent review of the following journal article: stulik, j. , et al. (2007). Total spondylectomy of c2: a new surgical technique. Acta chirurgiae orthopaedicae et traumatologiae cechosl. , 74, 2007, p. 79-90. (b)(6). The study objective was to evaluate total spondylectomy of c2 with preservation of roots, preservation of vertebral arteries and a short fixation without occipitocervical fusion. The case study included one patient, a man, (b)(6) who underwent total spondylectomy of c2. In 2001, he underwent a thyroidectomy for adenocarcinoma of the thyroid. In 2005, he was reoperated on for a local recurrence of the tumour. In (b)(6)2006, the patient complained of pain in the neck. The attending physician indicated a wholebody pet ct scan that revealed a solitary pathological process in the epistropheus. The patient went for additional examination and determination of the subsequent therapy. Subsequently, the entire posterior epistropheus was resected, including most of the pedicles and the entire articular processes for c2-c3 articulation. During dissection, the dural sac was damaged in the region of the attachment of the left root, which was treated by suture and covered with fibrin sealant. Non-synthes screws 4. 0 mm thick, were inserted into the lateral masses of the atlas and 4. 0mm screws into the c3 and c4 articular processes. On both sides, the screws were connected with non-synthes 3. 2mm rods, and a non-synthes transverse stabilizer was then applied to fix the two sides together. Cancellous bone grafts were harvested from the iliac crest and a massive posterolateral and posterior fusion of c1-c4 was performed. After the first surgery, no complications were encountered until 17th day when soft resistance posteriorly was detected in the region of the surgical wound, with fluctuation. Suspected liquorrhea was confirmed by puncture. Revision of the wound and repair of the dura mater was scheduled simultaneously with the anterior surgery. The second operation was performed after 21 days. For the anterior procedure between c1 - c3, a shaped synmesh cage with implanted. No additional fixation was needed. The mandible was fixed by two non-synthes miniplate system plates supported by an unknown dental plate. A catheter was inserted in the lumbar region. The patient was provided with a rigid philadelphia collar. The following complications were reported: the patient underwent a bilateral revision. The posterior approach was revised. The transverse stabilizer and autografts were removed. There was a defect in the dura mater in the region of the attachment of the c2 root on the left side. The defect was repaired. The patient was turned and the partially disintegrated wound in the mucosa of pharynx was revised. The defect was repaired, the liquor transmucously was drained off from the cage with a syringe and fibrin glue was applied inside. The lumbar drain was left in place draining off about 350 ml of liquor daily. Post-operatively, control radiographs show the caudal end of the cage is displaced by 1 mm anteriorly. This is report 1 of 1 for (b)(4). This report is for an unknown synmesh titan cage, unknown part # / lot #.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-12550 |
| MDR Report Key | 5636790 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-06 |
| Date of Report | 2016-04-22 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-06 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2016-05-06 |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-06 |