MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-08-08 for TL+ METAL DISTRACTION / COMPRESSION NUT 50-13010 manufactured by Orthofix Srl.
[154537072]
Analysis of historical records: the device involved in this event has not been returned to orthofix (b)(4) yet. Unfortunately also the lot number has not been made available and therefore it was not possible to perform the verification of the historical data. Technical evaluation: the device involved in this event has not been returned to orthofix (b)(4) yet. The technical evaluation will be performed as soon as the device is received. Medical evaluation: the information available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation are available. As soon as the results of the technical investigation become available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
[154537073]
The information provided by the local distributor indicates: hospital name: (b)(6) hospital. Surgeon name: dr (b)(6). Patient's initials: (b)(6). Problem observed during treatment. Type of problem: device functional problem. Event description: dr. (b)(6) from the same institution, he informed me about two patients of him operated on with truelock, who presented jamming of the lengthening nuts, during the treatment. So the tutor had to withdraw and put an intramedullary nail as a solution. No other information was provided. Manufacturer reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00053 |
| MDR Report Key | 8872963 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-08-08 |
| Date of Report | 2019-10-04 |
| Date Mfgr Received | 2019-10-03 |
| Date Added to Maude | 2019-08-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TL+ METAL DISTRACTION / COMPRESSION NUT |
| Generic Name | TL+ METAL DISTRACTION / COMPRESSION NUT |
| Product Code | LXT |
| Date Received | 2019-08-08 |
| Model Number | 50-13010 |
| Catalog Number | 50-13010 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-08 |