D
Patient 1
IT WAS REPORTED THAT THE CEMENT CANNOT BE FILLED INTO THE SYRINGE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
MAUDE MDR 3156863
- MDR report key
- 3156863
- Report number
- 2939274-2013-00010
- Event key
- 0
- Event type
- 3
- Date received
- 2013-06-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LINDA PLEWS
- Address
- 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
- Phone
- 800-800-8006
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NORIAN DRILLABLE 10 CC | SYNTHES NORIAN | OIS | SRS-1000-FRI | N998500 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-06-08 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT AFTER MIXING IN THE ROTATION MIXER, THE CEMENT COULD NOT BE FILLED INTO THE SYRINGE AND IT HARDENED.
N
Patient 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MIXING SYSTEM WAS RETURNED TO US AND WE HAVE FORWARDED THE ARTICLE IN QUESTION TO OUR PRODUCT MANAGER IN CHARGE FOR FURTHER ANALYSIS. UNFORTUNATELY, WE CANNOT REPRODUCE THE EXACT REASON FOR THE PROBLEM THAT APPEARED. IN THE POUCH, AN EVENLY DISTRIBUTED CEMENT IS VISIBLE WHICH INDICATES THAT THE MIXING PROCESS WAS IN ORDER. WE CAN ONLY SURMISE THAT THE TRANSFER PROCESS OF THE MIXER HAD BEEN DEFECTIVE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. CONCLUSION ? SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON AND CURRENTLY THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE.
N
Patient 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.
N
Patient 1
ADDED PART EXPIRATION DATE OF 03/31/2012. (B)(4). BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.