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 2019-10-10 for SAGITTAL IN-SITU BENDER, RIGHT 299704200 manufactured by Medos International Sàrl Ch.
[176840865]
(b)(4). The device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. 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
[176840866]
During an ais correction with expedium verse dr. (b)(6) performed some in-situ bending of the cocr rods after they were fully seated in the screws and all set screws were final tightened. During the bending of the second rod the in-situ bender brock. No patient harm occurred and the procedure could be completed by using the other side of the rod bender. In addition, during the screw loading on the screw driver, it disassembled itself. The screw driver shaft unlocked itself from the outer sleeve when loading the screw. Specifically the screw driver shaft got pushed out of the sleeve distally during the last turns of loading the screw. The nurse was able to re-create the disassembly by just pulling and simultaneously rotating the screw driver shaft in the sleeve. It seems the retaining mechanism of the outer sleeve is damaged / worn. To complete insertion of the screws we just used the 2nd screw driver from the set. If other, describe: revision surgery of previous ais correction with expedium difar due to progressing lumbar curve below the initial construct. , was surgery delayed due to the reported event? : no, action taken when event occurred? : used the other side of the instrument, was procedure successfully completed? : yes, were fragments generated? : yes, if yes, were they removed easily without additional intervention? : yes, patient status/ outcome / consequences: no, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study: no. Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: 1), unknown screw (part#: unknown, lot#: unknown, quantity: unknown). This complaint involves three (3) device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-52231 |
| MDR Report Key | 9174478 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-10 |
| Date of Report | 2019-09-18 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2019-09-18 |
| Date Added to Maude | 2019-10-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAGITTAL IN-SITU BENDER, RIGHT |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-10-10 |
| Returned To Mfg | 2019-10-08 |
| Model Number | 299704200 |
| Catalog Number | 299704200 |
| Lot Number | GB103407 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-10 |