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 2020-01-08 for 5.5 EXP VERSE FEN SCR 7.0X50 199723750 manufactured by Medos International Sàrl Ch.
[176679392]
(b)(4). Visual examination found the external threads of the device were slightly worn. There was light discoloration along the shaft and head of the device. The reduction tabs were broken from the screw head however this is consistent with normal use of the device. The screw heads internal threads were completely broken from the screw head, no fragments were returned. The inner core of the screw head had shear marks from the broken internal threads. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. Although no definitive root-cause can be determined, it is possible the threads were damaged due to unintended forces during either implantation or explantation. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.
Patient Sequence No: 1, Text Type: N, H10
[176679393]
Two correction keys of expedium verse broke apart while tightening with torque limiting handle. Correction keys and screw were replaced with a new correction key and new screw. Delay of surgery was about 15min. 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: unknown. Is the patient part of a clinical study: unknown. Ip-00762218 device property of: none. Device in possession of: none. Ip-00762219 device property of: none. Device in possession of: none. By checking this box i certify that all information that are known/available has been disclosed. If any new information will be made available, the additional information will be submitted through cst. True. Concomitant device reported: unknown torque limiting handle (part#: unknown, lot#: unknown, quantity: 1). This complaint involves three (3) devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00251 |
| MDR Report Key | 9563547 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-08 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-06 |
| Device Manufacturer Date | 2019-08-12 |
| Date Added to Maude | 2020-01-08 |
| 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 | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.5 EXP VERSE FEN SCR 7.0X50 |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Product Code | MNI |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-09 |
| Catalog Number | 199723750 |
| Lot Number | 251989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-08 |