MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-13 for HTR-PMI A.B. 1953-20190619 RIGHT TOP PARIETAL IMPLANT N/A PM622209 manufactured by Biomet Microfixation.
[179410200]
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. It is unknown at this time if the device will be returned for evaluation. The product remains implanted in the patient, but a revision is planned for a later unspecified date at which time the device may be returned for testing. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00108, 0001032347-2020-00109. Concomitant medical products: htr-pmi a. B. 1953-20190619 right top parietal implant, part# pm622209, lot# 917120; 1. 5mm system 4 hole extra long straight plate, part# 01-7048, lot# unknown; 1. 5mm system high torque (ht),sd,x-dr,scr,5/pk, part# 91-6104, lot# unknown; unknown screws, part# unknown, lot# unknown. The user facility is foreign; therefore a facility medwatch report will not be available. Report source? (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[179410201]
It was reported the patient will undergo a revision of a custom cranial plate due to unspecified medical issues. The custom cranial implant will be removed and will be replaced with a new custom cranial implant. Attempts have been made and no additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00107 |
| MDR Report Key | 9709333 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER DELANEY |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR-PMI A.B. 1953-20190619 RIGHT TOP PARIETAL IMPLANT |
| Generic Name | CUSTOM MADE DEVICE |
| Product Code | KKY |
| Date Received | 2020-02-13 |
| Model Number | N/A |
| Catalog Number | PM622209 |
| Lot Number | 917120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-13 |