MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-03-28 for 5.5 EXP VERSE FEN SCR 8.0X50 199723850 manufactured by Medos International Sàrl Ch.
[140159525]
(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
[140159526]
It was reported that patient returned for revision of spine instrumentation due to left side s1 pedicle screw disengaging from rod. If other, describe. L3-s1 posterior fusion with alif l5s1 and lateral cage l3-4. Did the patient experience a post-op device malfunction? Yes. If yes, please describe. Left side s1 pedicle screw disengaging from rod. Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? No. Did the patient require revision surgery or hardware removal? Yes. Was device explanted? True. Did patient require revision surgery? True. If yes, date of revision surgery. On (b)(6) 2019. Patient status/ outcome / consequences: unknown. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required? Unknown. Is the patient part of a clinical study? Unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51491 |
| MDR Report Key | 8459713 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-06 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2017-11-15 |
| Date Added to Maude | 2019-03-28 |
| 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 | 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 8.0X50 |
| Generic Name | BONE CEMENT, POSTERIOR SCREW AUGMENTATION |
| Product Code | PML |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-03-25 |
| Model Number | 199723850 |
| Catalog Number | 199723850 |
| Lot Number | 168866 |
| 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 | 1. Required No Informationntervention | 2019-03-28 |