MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-01-03 for HTR * PMI ACEBO SAENZ BI-FRONTAL PARIETAL IMPLANT N/A PM617732 manufactured by Biomet Microfixation.
[96319881]
(b)(4). Concomitant medical product: biomet microfixation plates catalog #: ni, lot #: ni; biomet microfixation screws catalog #: ni, lot #: ni. Therapy date: (b)(6) 2016. Patient code(s)- no code available for papular lesions. (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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
[96319882]
It was reported a revision was performed due to infection. The patient suffered traumatic injuries in a motorcycle accident, therefore a frontal craniotomy was performed. This left a bone defect from the superior orbital rim bilaterally, the frontal, and extension to both temporal. A patient matched implant made of porous methyl methacrylate was requested and was implanted in (b)(6) 2016. Subsequently it evolves with papular lesions and later fistulas skin at the frontal level obtaining positive culture to staphylococcus aureus. It was decided to remove the implant on approximately four months post operative. Fibrous capsule and tissue were found transoperatively granulation as well as purulent exudate between the coronal flap and the implant. When removing the implant hematopurulent exudate was also obtained underneath it, also positive to staphylococcus aureus. It evolves satisfactorily, without infection data coronal flap healing, absence of collection data demonstrated by ct and mri. It is reported the patient will have a revision to remove the second implant due to infection. This event is reported in 0001032347-2018-00002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00004 |
| MDR Report Key | 7160184 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-01-03 |
| Date of Report | 2018-06-28 |
| Date of Event | 2016-11-07 |
| Date Mfgr Received | 2018-05-30 |
| 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 |