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 2018-08-30 for HTR*PMI INACIO DOS SANTOS SILVA LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620655 manufactured by Biomet Microfixation.
[118886442]
(b)(4). Report source: foreign country - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, it is 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
[118886443]
It was reported during the surgery the implant did not fit the patient like it was fitting at the model. The surgeon was worried that the skull used to design the implant was bigger than the patient? S actual skull. The design vendor reported after seeing the pre-op and post -op images together, the surgeon decided that she was satisfied with the results. No adverse events have been reported as a result of the malfunction. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00587 |
| MDR Report Key | 7835182 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-08-30 |
| Date of Report | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2018-08-30 |
| 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 INACIO DOS SANTOS SILVA LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2018-08-30 |
| Model Number | N/A |
| Catalog Number | PM620655 |
| Lot Number | 835180 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-30 |