MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-07-19 for BONE GRAFTING MATERIAL, SYNTHETIC manufactured by Synthes Usa.
[80402235]
Device product code? Xxx? Used as the code applicable to? Bone grafting material, synthetic? Was not available for selection. The actual device code is? Lyc?. This report is for unknown chronos granules. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Complainant device is not expected to be returned for manufacturer review/investigation. (510k): unknown, as specific part and lot numbers for chronos granules is not provided. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[80402236]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the patient recently underwent a procedure where chronos granules were placed on the temporal lobe area of the head and the patient is now experiencing extreme pain and other complications. This report is for unknown chronos granules. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11944 |
| MDR Report Key | 6724323 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BONE GRAFTING MATERIAL, SYNTHETIC |
| Product Code | LYC |
| Date Received | 2017-07-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-19 |