MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-07 for EXP A 5.0 TAP 279751005 manufactured by Medos International Sàrl Ch.
[176629098]
Complainant part is not expected to be returned for manufacturer review/investigation. 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
[176629099]
It was reported that on (b)(6) 2019, during a spinal fusion surgery, while the surgeon was tapping the l2 pedicle with the patient presented with sclerotic bone, the expedium 5. 0mm tap broke in the pedicle. A universal hardware removal (uhr) set was opened, using the trephines and screw extractors, the surgeon was able to successfully remove the broken tip of the screw from the patient and the tap was fully retrieved. The broken tap tip was successfully retrieved and compared to the tap? S shaft. All pieces were confirmed by the rn and surgeon in the operating room. There were no fragments generated. Thus, final x-rays were taken to confirm no broken pieces of tap were left behind. There was a surgical delay of 50-60 minutes. The procedure was completed. The patient's status was unknown. Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: unknown). This report is for one (1) exp a 5. 0 tap. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00209 |
| MDR Report Key | 9558924 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MEDOS INTERNATIONAL S |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXP A 5.0 TAP |
| Generic Name | TAP,BONE |
| Product Code | HWX |
| Date Received | 2020-01-07 |
| Catalog Number | 279751005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-07 |