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 2020-03-10 for 4.0MM TI CANCELLOUS POLYAXIAL SCREW 50MM 04.614.150 manufactured by Oberdorf Synthes Produktions Gmbh.
[183122395]
Additional device product codes: kwp; mnh; mni. Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. Reporter is synthes sales consultant. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[183122396]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was implanted with hardware about an year ago. On an unknown postoperative date it was identified that the head of the spongy synapse screw broke off. Patient underwent the revision surgery on an unknown date. No further information provided regarding surgery outcome and patient. Concomitant device reported: cancellous polyaxial screw (part # 04. 614. 134, lot # unknown, quantity 2); unknown rods (part # unknown, lot # unknown, quantity 2). This report is for one (1) 4. 0 mm ti cancellous polyaxial screw 50mm. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01782 |
| MDR Report Key | 9813741 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.0MM TI CANCELLOUS POLYAXIAL SCREW 50MM |
| Generic Name | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION |
| Product Code | NKG |
| Date Received | 2020-03-10 |
| Catalog Number | 04.614.150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |