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 2018-01-03 for HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANT N/A PM617732 manufactured by Biomet Microfixation.
[96334331]
(b)(4). Concomitant medical products: biomet microfixation neuro plates, catalog #: ni, lot #: ni; biomet microfixation neuro screws, catalog #: ni, lot #: ni. (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96334332]
It is reported a second revision will occur due to an infection. "[the first implant] evolves satisfactorily, without infection data coronal flap healing, absence of collection data demonstrated by ct and mri. Given this panorama it was decided to place the second implant [during the fourth quarter of] 2017. The patient evolved with scar healing until [approximately a month following the implantation] until [approximately a month later] in which there appears a frontal ulceration approximately five cm anterior to the coronal access scar with serous material, pending result of culture of exudate, there is also diffuse cutaneous flushing in the coronal flap. The patient will again submit to surgical treatment for removal of the implant in the near future, having completed the pre-operative study protocol. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00002 |
| MDR Report Key | 7160391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-03 |
| Date of Report | 2018-06-29 |
| Date Mfgr Received | 2018-05-31 |
| Device Manufacturer Date | 2016-04-28 |
| Date Added to Maude | 2018-01-03 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANT |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2018-01-03 |
| Model Number | N/A |
| Catalog Number | PM617732 |
| Lot Number | 674830 |
| ID Number | (01)00841036208226 |
| Device Expiration Date | 2019-04-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-01-03 |