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 2020-03-27 for MAXILLARY DISTRACTOR BODY 15MM 288.026S manufactured by Oberdorf Synthes Produktions Gmbh.
[186532883]
The event date is unknown in the year 2020. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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
[186532884]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during removal of the maxillary distractor main body the right device broke at its tip. It was unknown if there was a surgical delay. Procedure outcome was unknown. Patient outcome was stable. Concomitant devices reported: anti foot plate left (part # 288. 043s, lot # h311834, quantity # 1), anti foot plate right (part # 288. 039s, lot # h480997, quantity # 1), oval head screw (part # 288. 065s, lot # unknown, quantity (2), post foot plate (part # 288. 056s, lot # 9858022, quantity 2). This complaint involves one (1) device this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02355 |
| MDR Report Key | 9890880 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXILLARY DISTRACTOR BODY 15MM |
| Generic Name | BONE PLATE |
| Product Code | JEY |
| Date Received | 2020-03-27 |
| Catalog Number | 288.026S |
| Lot Number | H438204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |