MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-10-22 for THERABITE JAW MOTION REHABILITATION SYSTEM, ADULT TH001 manufactured by Atos Medical Ab.
[3796101]
During another complaint issue the patient mentioned that he had got a broken jaw presumably from using the therabite jaw rehabilitation system.
Patient Sequence No: 1, Text Type: D, B5
[11140874]
The product is not available for investigation. Information provided by the customer is very limited and all efforts to obtain more information have failed. The upper mouthpiece has a design which purpose is to make it dislodge if the force is too high. This is to protect the patient from harm caused by too high exercising force. Tests have been performed to evaluate the mechanical strength of the therabite (tr-05-061). Amongst the samples tested the average strength was 356n and the sample with the highest mechanical strength was measured to 366n. According to studies (sathyanarayna, h. P. , premkumar, s,. 2012 and waltimo, a. , k? N? Nen, m. , 1993) the maximal bite force of healthy subjects are for women around 550-600n and for male 650-850n. This is at least ~200n above the force that would break the therabite, this means that the force to break the therabite would easily be reached by healthy individuals before any damage comes to the jaw. This strongly suggests that the patient has some kind of weakening of the jaw. In the ifu weakening of the jaw is a clear contraindication. Contraindications the therabite system should not be used by individuals who have or may have a fracture in the maxilla or mandible (upper or lower jaw) or other weaknesses of the bones of the jaw. Patients with infections of the jaw, osteomyelitis, or osteoradionecrosis of the jaw should not use the therabite system. Additionally in the warnings-section of the ifu patients are cautioned: injury may occur if excessive force is applied while using the therabite system, especially in users with weakened dentition, periodontal disease, weakened bones or joints, or gap-bridging plates. Users should disclose any such condition to their clinician before using the therabite system and should exercise extreme caution while using the product. Conclusion/action: the built in security feature in the mouth pieces secure that excessive force cannot be administered to the structures of the jaw. It can therefore be assumed that the patient has some type of condition that causes weakening of the jaw. In the ifu it is clearly contraindicated for patients with weakened jaw to use the device. No product malfunction. The patient has already been advised to stop using the device. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2013-00007 |
| MDR Report Key | 3421920 |
| Report Source | 07 |
| Date Received | 2013-10-22 |
| Date of Report | 2013-10-22 |
| Date Mfgr Received | 2013-09-23 |
| Date Added to Maude | 2013-10-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 |
| Manufacturer City | HORBY, SE-242 2 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABITE JAW MOTION REHABILITATION SYSTEM, ADULT |
| Generic Name | JAW REHABILITATION TRAINER |
| Product Code | ION |
| Date Received | 2013-10-22 |
| Model Number | TH001 |
| Catalog Number | TH001 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-22 |