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 2018-03-12 for HTR-PMI HASEWINKEL LEFT FRONTAL SPHENOID TEMPORAL IMPLANT N/A PM620185 manufactured by Biomet Microfixation.
[102113818]
(b)(4). Unique identifier (udi) #: (b)(4). Report source: foreign country - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, 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
[102113819]
It was reported the cranioplasty implant did not fit; "curvature wouldn? T be in the correct direction. " the surgeon modified the implant a bit, he ended up cutting the implant into two pieces and implanting both pieces. There was a surgical delay of about one hour. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00121 |
| MDR Report Key | 7331156 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-12 |
| Date of Report | 2018-08-31 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2017-12-05 |
| Date Added to Maude | 2018-03-12 |
| 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 HASEWINKEL LEFT FRONTAL SPHENOID TEMPORAL IMPLANT |
| Generic Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Product Code | KKY |
| Date Received | 2018-03-12 |
| Model Number | N/A |
| Catalog Number | PM620185 |
| Lot Number | 797130 |
| ID Number | SEE H10 NARRATIVE |
| 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. Required No Informationntervention | 2018-03-12 |