MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for SAGITTAL IN-SITU BENDER, RIGHT 299704200 manufactured by Medos International Sàrl Ch.
[137950259]
(b)(4). 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
[137950260]
It was reported that the surgeon had 3 instruments break during a t3-ilium revision spinal fusion. All instruments broke while the surgeon was using them to preform various functions in the case. Was surgery delayed due to the reported event? Unknown. Was procedure successfully completed? Unknown. Were fragments generated? Unknown. If yes, were they removed easily without additional intervention? Unknown. 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? Unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51315 |
| MDR Report Key | 8309947 |
| Date Received | 2019-02-06 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2016-08-19 |
| Date Added to Maude | 2019-02-06 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES SPINEDEPUY 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 | 0 |
| Brand Name | SAGITTAL IN-SITU BENDER, RIGHT |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-02-06 |
| Returned To Mfg | 2019-01-23 |
| Model Number | 299704200 |
| Catalog Number | 299704200 |
| Lot Number | GB77760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-02-06 |