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 2020-03-27 for UNK - LOCKING/SET SCREWS: SYNAPSE manufactured by Oberdorf Synthes Produktions Gmbh.
[186539875]
510k: this report is for an unknown synapse locking/set screw/unknown lot. Part and lot number are unknown; udi number is unknown. Additional narrative: kwp, mnh, mni. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Product was received. 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
[186539876]
Device report from synthes germany reports an event as follows: it was reported intraoperatively two synapse screw heads loosened. Concomitant devices: synapse screw collars/sleeves/heads (part unknown, lot unknown, quantity unknown); cancellous synapse screw (part 04. 614. 240, lot h310485, quantity 1); cancellous synapse screw (part 04. 614. 238, lot 7656522, quantity 1) this report is for a synapse locking/set screw. This is report 3 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02340 |
| MDR Report Key | 9887761 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-27 |
| 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 WRIGHT 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 |
| Brand Name | UNK - LOCKING/SET SCREWS: SYNAPSE |
| Generic Name | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION |
| Product Code | NKG |
| Date Received | 2020-03-27 |
| 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 | 2020-03-27 |