MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,foreign, report with the FDA on 2017-08-04 for HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT N/A PM617936 manufactured by Biomet Microfixation.
[81809770]
(b)(4). The user facility is foreign; therefore a facility medwatch report will not be available. Review of device history records show the lot released with no recorded anomaly or deviation. The warnings in the package insert state this type of event can occur. A post-operative comparison was provided by the design vendor. The comparison was reviewed and no obvious fracture was observed, however this may be due to the slice spacing or transfer to the comparison. A post-operative ct scan was requested as review of the actual ct scan may be more conclusive. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[81809771]
The distributor reported the patient feels that the implant is cracked and the surgeon confirms this thought due to a crunching sound.
Patient Sequence No: 1, Text Type: D, B5
[119402172]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[119402173]
Additional information was received; it was reported "it has been shown, that there was an insufficient fixation of the implant which has lead to noises while movement between implant and bone. " in regards to the insufficient fixation of the implant it is stated there was "insufficient technique because of high brain pressure. " the issue was identified 2-3 weeks after surgery and was resolved by re-fixating the cranioplasty implant with screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00629 |
| MDR Report Key | 6766700 |
| Report Source | CONSUMER,DISTRIBUTOR,FOREIGN, |
| Date Received | 2017-08-04 |
| Date of Report | 2018-01-30 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2016-04-28 |
| Date Added to Maude | 2017-08-04 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT |
| Generic Name | HTR PMI LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Product Code | KKY |
| Date Received | 2017-08-04 |
| Model Number | N/A |
| Catalog Number | PM617936 |
| Lot Number | 680340 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2019-04-28 |
| Operator | DEVICE UNATTENDED |
| 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 | 2017-08-04 |