MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-10-07 for TL+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM 54-11530 manufactured by Orthofix Srl.
[169892878]
Analysis of historical records. The devices involved in this event have not been returned to orthofix (b)(4) yet. Unfortunately also the lot numbers have not been made available and therefore it was not possible to perform the verification of the historical data. Technical evaluation. The devices involved in this event have not been returned to orthofix (b)(4) yet. The technical evaluation will be performed as soon as the devices are made available. 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 investigation become available, orthofix (b)(4) will provide you with a follow up report. Orthofix (b)(4) continues monitoring the devices on the market. Please kindly refer also to mfr report number 9680825-2019-00066. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[169892879]
The information provided by the local distributor indicates: hospital name: (b)(6) hospital. Surgeon name: dr (b)(6). Date of initial surgery: (b)(6) 2019. Body part to which device was applied: tibia surgery description: n/a. Patient information: male, (b)(6) kg. Problem observed during: into treatment/post-operative. Type of problem: device functional problem. Event description: on (b)(6) 2019, during one of the clinic visit, dr. (b)(6) realized that there were 2 pin fixation bolts that were "cracked" (pictures provided by the local distributor). The complaint report form also indicates: the device failure did not cause any adverse effects on patient. The initial surgery was completed with the device. The event did not lead to a clinically relevant increase in the duration of the surgical procedure. An additional surgery was not required. Copies of the operative reports and x-ray images are not available. Patient current health condition: n/a. Further information received from the local distributor on (b)(6) 2019: the two devices are still on patient. They will not be returned back to orthofix (b)(4). Patient's current health condition: patient is walking and i hope that the pin fixation bolt will not break. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2019-00065 |
| MDR Report Key | 9161552 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-10-07 |
| Date of Report | 2019-11-07 |
| Date Mfgr Received | 2019-11-05 |
| Date Added to Maude | 2019-10-07 |
| 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. 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+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM |
| Generic Name | TL+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM |
| Product Code | LXT |
| Date Received | 2019-10-07 |
| Model Number | 54-11530 |
| Catalog Number | 54-11530 |
| 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 | 2019-10-07 |